Assessment African Countries

Assessment of medicines regulatory systems in sub-Saharan African countries An overview of findings from 26 assessment reports

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Assessment of medicines regulatory systems in sub-Saharan African countries

An overview of findings from 26 assessment reports

WHO/EMP/QSM/2010.4

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Assessment of medicines regulatory systems in sub-Saharan African countries

An overview of fi ndings from 26 assessment reports


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1 As se s s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s

ContentsAcknowledgements ......................................................................................................................................2

Abbreviations ....................................................................................................................................................3

Executive summary ..................................................................................................................................... 4

1 Introduction ...............................................................................................................................................6 1.1 Medicines regulation in developing countries ................................................................................................................................ 6

1.2 Overview of regulatory elements ......................................................................................................................................................... 6

1.3 Aim of this report ....................................................................................................................................................................................... 7

2 Method .........................................................................................................................................................7

3 Results ..........................................................................................................................................................8 3.1 Country profi les ........................................................................................................................................................................................... 8

3.2 Regulatory framework .............................................................................................................................................................................. 9

3.3 Structure and management .................................................................................................................................................................12

3.4 Medicines registration (marketing authorization) ......................................................................................................................13

3.5 Licensing of activities ..............................................................................................................................................................................16

3.6 Import and export control .....................................................................................................................................................................16

3.7 Inspections ...................................................................................................................................................................................................17

3.8 Quality control ...........................................................................................................................................................................................18

3.9 Market surveillance (product quality monitoring, pharmacovigilance, control of promotion and advertising) ......... 18

3.10 Oversight of clinical trials ......................................................................................................................................................................20

4 Conclusions ............................................................................................................................................... 21

Annexes ........................................................................................................................................................... 22 ANNEX 1: Geographical, socio-economic and pharmaceutical indicators ..................................................................................22

ANNEX 2: Organizational structure and implementation of regulatory functions ..................................................................24

ANNEX 3: Organizational structure and management ........................................................................................................................26

ANNEX 4: Marketing authorization..............................................................................................................................................................28

ANNEX 5: Licensing of activities ....................................................................................................................................................................31

ANNEX 6: Import control ..................................................................................................................................................................................32

ANNEX 7: Inspections ........................................................................................................................................................................................34

ANNEX 8: Quality control .................................................................................................................................................................................36

ANNEX 9: Market surveillance ........................................................................................................................................................................38

References ........................................................................................................................................................41

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2 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s

This report summarizes the fi ndings of 30 assessments of regulatory systems carried out by assessment teams on behalf of WHO’s Department of Essential Medicines and Pharmaceutical Policies (EMP). The countries visited are listed in Annex 1 of this report. WHO would like to thank the governments of these countries, and the respondents during the assessment visits, for their cooperation and support.

The assessments were conducted by the following experts on behalf of WHO: Dr Adebowale Adeoye (WHO/DFID), Dr Abubakr Abdelraouf Alfadl (Sudan), Mr Mohamed Imadin Atabani (Sudan), Mr Benjamin Botwe (Ghana), Mrs Kari Bremer (Norway), Dr Andrew K. Chemwolo (Kenya), Mr Felix Peter Chizu (Zambia), Dr Mory Fofana (Guinea), Mrs Mariama Gamatie, Mr Ishmael Joseph, Mr Rutendo Kuwana (Zimbabwe), Mrs. A. C. Madukwe (Nigeria), Mr Einar Magnusson (Iceland), Ms. Gugu N Mahlangu (Zimbabwe), Dr Minkaila Maiga (Mali), Mr Deus Mubangizi (Uganda), Dr Anastasie Mulumba (WHO), Mr Viateur Mutanguha (Rwanda), Dr Margareth Ndomondo-Sigonda (Tanzania), Professor Tamás Paál (Hungary), Dr Alain Prat (WHO), Dr Nicole Ridolphi (France), Mr. Adetona Saka (WHO/DFID), Dr Burhani Othman Simai (Zanzibar), Mr Hiiti Sillo (Tanzania), Dr Stanley Soyona (EAC), Dr Ogori Taylor (Nigeria), Professor Amor Toumi (WHO), Dr Jean-Marie Trapsida (WHO-

AFRO), Professor Charles Wambebe (WHO/DFID) and Mr Eshetu Wondemagegnehu (WHO).

The Swedish International Development Cooperation Agency (SIDA) and the European Commission (EuropeAid Co-operation Offi ce) provided fi nancial support for the assessment visits.

Dr Alain Prat further improved the WHO data collection tool for the assessments as well as a detailed guidance document for its use, building on the pioneering work of Eshetu Wondemagegnehu and Dr Valerio Reggi (WHO). He also prepared a background document synthesizing the main fi ndings of 21 country assessments and giving conclusions based on his experience as a member of nine of the missions and from his ongoing work in assisting the regulatory authorities of the countries assessed.

Mrs Monika Zweygarth prepared the draft report. Dr Alain Prat, Dr Samvel Azatyan, Dr Amor Toumi and Dr Lembit Rägo provided valuable input.

Acknowledgements


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3 As ses s ment o f me d i c ine s r e gu l a t or y s y s t e ms in su b - S ah ar an Af r i c an count r i e s

Abbreviations

API Active pharmaceutical ingredient

BCS Biopharmaceutical Classifi cation System

BE Bioequivalence

CIOMS Council of International Organization of Medical Sciences

COA Certifi cate of analysis

CPP Certifi cate of pharmaceutical product

CTD Common technical document

DMF Drug Master File

EAC East African Community

EMEA European Medicines Agency

FPP Finished pharmaceutical product

GCP Good Clinical Practices

GDP Good Distribution Practices

GMP Good Manufacturing Practices

GLP Good Laboratory Practices

GSP Good Storage Practices

ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals forHuman Use

ISO International Organization for Standardization

MA Marketing authorization

MoH Ministry of Health

NMRA National medicines regulatory authority

NGO Non-governmental organization

OECD Organization for Economic Co-operation and Development

OTC Over-the-counter

PQP Prequalifi cation Programme (WHO)

PV Pharmacovigilance

QA Quality assurance

QC Quality control

SOP Standard operating procedure

SPC Summary of product characteristics

UMC Uppsala Monitoring Centre (WHO Collaborating Centre for International Drug Monitoring hosting Global Database of Adverse Drug Reaction reports)

US FDA United States Food and Drug Administration

USA United States of America

WHO World Health Organization



Executive summary

Medicines regulation is needed to ensure that all pharmaceutical products on the market are safe, effective and consistently meet approved quality standards [1].

WHO works with Member States in assessing national regulatory systems to identify gaps, develop strategies for improvement and support countries in their commitment to build national regulatory capacity.

This report synthesizes the fi ndings of rapid assessments performed at national medicines regulatory authorities (NMRAs) in 26 African countries over the last eight years. It is mainly based on the reports provided to the countries by the assessment teams. Although the emphasis of the missions was on capacity-building rather than a standardized comparison of indicators, the fi ndings are thought to give a reasonable overview of the regulatory situation in Africa at the time of the visits.

1. Country profiles

Most of the countries visited had limited economic resources as well as a high burden of illness, limited pharmaceutical manufacturing capacity and a diverse pharmaceutical supply chain.

2. Regulatory framework

Strengths: All countries had legal provisions in place which designated an NMRA and defi ned its main functions. Several countries were committed to giving their NMRAs more autonomy in terms of management and funding.

Weaknesses: The legal framework was complex, with unclear defi nitions of responsibilities, resulting in regulatory gaps and overlaps. Some NMRAs were not fully established. In many countries not all regulatory functions were operational.

3. Structure and management

Strengths: Overall, countries showed increasing awareness of the importance of independence, impartiality and transparency in medicines regulation. Many staff members were motivated and professional despite diffi cult working conditions.

Weaknesses: Most NMRAs lacked sustainable funding. There was a universal shortage of qualifi ed staff and operational resources. Quality Management Systems covering regulatory procedures, specifi c development programmes to keep staff abreast of current

technology and science, and specifi c measures to assure confi dentiality and to avoid confl icts of interest were generally absent.

4. Medicines registration (marketing authorization)

Strengths: The majority of countries had a legal basis for medicines registration in place, and had drafted supporting documents for applicants and for assessors. Advisory committees were widely used, and to a certain extent expertise of external assessors was sought for medicines registration.

Weaknesses: Guidelines and assessment procedures were not up to WHO standards, and were often of an administrative rather than technical nature. There were wide-ranging exemption clauses not justifi ed by a risk assessment, for example for public sector imports or donations. There were few mechanisms in place to ensure the impartiality and technical competence of external assessors. Scarce resources severely limited technical assessment of dossiers. In spite of resource constraints few countries relied on decisions made by other regulators such as stringent NMRAs or by the WHO Prequalifi cation Programme. Regulatory decisions by other competent authorities were not widely recognized.

5. Licensing of activities

Strengths: Countries generally had legal provisions for licensing pharmaceutical activities, including manufacturing, wholesale, import/export, distribution and retail sale.

Weaknesses: Licensing was not implemented effi ciently. This function was not under the sole control of the NMRA in most cases, and some of the authorities involved had no technical capacities. Poor coordination and poor information management resulted in regulatory gaps.

6. Import and export control

Strengths: In most countries, only medicines with marketing authorization were eligible for import.

Weaknesses: Systems to verify the marketing authorization or exemption status of products on importation were ineffi cient or absent in many countries. There was poor coordination among the authorities involved. Mechanisms to control exported medicines were either absent, or not stringently enforced.




7. Inspections

Strengths: Structures existed to inspect pharmaceutical establishments for compliance with national guidelines.

Weaknesses: This function was often shared with other authorities, and inspections were not well coordinated. Guidelines were not in line with WHO standards for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Lack of qualifi ed inspectors, transport and communication severely limited the number and quality of inspections conducted.

8. Quality control (QC)

Strengths: The majority of countries had a regulatory QC laboratory. Most laboratories had qualifi ed staff, and many had adequate, serviceable equipment. Several laboratories were committed to implementing a QMS.

Weaknesses: Few laboratories had an effective QMS in place. QC testing was not used optimally to complement other regulatory functions.

9. Market surveillance (product quality monitoring, pharmacovigilance, control of promotion and advertising)

Strengths: Most countries had some legal provisions and structures in place to monitor the safety, effi cacy and quality of medicines on the market.

Weaknesses: Implementation of post-marketing surveillance was poor. Quality monitoring was not prioritized based on risk, but was generally performed in case of complaints if at all. Few countries monitored adverse events to medicinal treatment or controlled promotion of pharmaceuticals systematically. Generally speaking, market surveillance measures were not suffi ciently integrated with other regulatory activities.

10. Oversight of clinical trials

Strengths: The majority of countries had provisions in place to control ethical aspects of clinical trials.

Weaknesses: Few NMRAs authorized the performance of clinical trials in their countries, and therefore very few authorities monitored clinical trials after approval. Links with ethics committees were often weak or non-existent. GMP was not assured for investigational products.

Conclusion

Structures for medicines regulation existed in the countries assessed, and the main regulatory functions were addressed, although in practice the measures were often inadequate and did not form a coherent regulatory system. Common weaknesses included a fragmented legal basis in need of consolidation, weak management structures and processes, and a severe lack of staff and resources. On the whole, countries did not have the capacity to control the quality, safety and effi cacy of the medicines circulating on their markets or passing through their territories. Regulatory capacity should be built urgently in African countries, using the following approaches:

Encourage and assist countries to assess their own •

regulatory systems in a systematic way in order to identify and address gaps.

Work towards consistent implementation of all •

essential regulatory functions in African countries, based on the key provisions in the existing legal frameworks.

Strengthen management structures, specifi c technical •

regulatory expertise and physical resources (both human and fi nancial) available to NMRAs in Africa.

Consider mechanisms for sharing the outcomes of •

regulatory assessments.



Medicines regulation in 1.1 developing countries

Medicines are essential to health care and must be available to the inhabitants of every country. Medicines regulation aims to ensure that medicines on national markets and in international commerce are safe, effective and of good quality, are accompanied by complete and correct product information, and are manufactured, stored, distributed and used in accordance with good practices.

Affordable products are increasingly becoming available which have the potential to reduce morbidity and mortality in resource-constrained countries dramatically. African countries import most of their pharmaceuticals. However, recently the African Union has started to promote local manufacture of medicines in Africa.

The increasing globalization of commerce and the merging of pharmaceutical companies are breaking down national boundaries in medicines supply. Substandard and counterfeit pharmaceutical products have been reported from all over the world [2]. The problem is greatest in developing countries, which have insuffi cient funds for medicines procurement, and even fewer resources to enforce quality standards and to protect the medicines supply chain.

The norms and standards for medicines quality are becoming more and more sophisticated. The assessment of new chemical entities is especially challenging. International norms and standards for medicines are thus more important than ever before. WHO continues to develop such norms and standards to serve as guidance for national regulatory systems. In practice however, quality standards of medicines are often adapted to the requirements in force in the destination country [3].

Regulating the increasingly complex channels of medicines supply requires constant vigilance, adaptation and considerable organizational capacity and resources. WHO’s constitutional mandate requires it to support member states in implementing regulatory mechanisms to international norms and standards. This report presents the results of assessments of regulatory systems conducted in 26 sub-Saharan African countries (24 belonging to the WHO AFRO region) over the last eight years to identify regulatory gaps and to suggest priority activities to strengthen regulatory capacity.

Overview of regulatory 1.2 elements

A host of challenges threatens the safety, effi cacy and quality of medicines at every stage of their life cycle: Weaknesses in research and development, defi ciencies in dosage form design, varying standards in ongoing production, damage during transport and storage, and inadequate use of products by prescribers and patients. An effective system must therefore provide the full range of regulatory functions, covering every stage of the cycle.

The main functions of an NMRA include control of pharmaceutical products by registration and post-marketing surveillance (quality monitoring and pharmacovigilance), as well as control of activities by licensing and inspection of manufacturers, importers, exporters, wholesalers, distributors, pharmacies and retail outlets, control of clinical trials and control of promotion of pharmaceuticals. These functions must work together to form a coherent medicines regulatory system (see Figure 1).

FIGURE 1: ALL FUNCTIONS OF A MEDICINES REGULATORY SYSTEM

Control of preclinical and clinical trials (GCP, GLP, GMP) for new chemical entities

Control of products Control of activitiesLicensing of manufacturer (GMP)

Product registration:Marketing authoriza-tion (MA) (based on evaluation of quality, safety, efficacy)

Quality Control (QC)(based on specifications)

DDEVELOPMENT

USEPharmacovigilance(monitor safety/efficacy of products)

Market surveillance(product quality)Monitoring of activities

Control of advertising(check claims against approved SPC)

DISTRIBUTIONLicensing of importer, wholesaler, distributor (GDP, GSP), pharmacy (GPP)

Control of import/export (based on MA)

Inspection

MANUFACTURE / IMPORT

Anti-counterfeiting programme

African pharmaceutical markets are mostly generic markets. The main difference between the life cycles of originator and generic medicines is in the development phase. While for innovator medicines the focus is on safety and effi cacy data (proven in preclinical and clinical trials), generic medicines are assumed to be safe and effi cacious if they are proven to be interchangeable with originators, and the focus is essentially on quality.

Introduction1.




Aim of this report1.3

This report aims to give an overview of the legal basis, structures, processes and implementation of medicines regulation in African countries. It is anticipated that it will help policy makers, funders and other interested stakeholders to better understand the situation and to design appropriate actions to strengthen regulatory systems in Africa.

Objectives

The objectives of this report are:

to highlight the main strengths and weaknesses • of medicines regulation in African countries;

to put the fi ndings into the context of the •

global regulatory situation and of internationally recommended standards for effective medicines regulation; and

to provide a baseline and perspective for future •

assessment strategies.

Method2.

The assessments summarized in this report were conducted during visits to NMRAs conducted in the period from 2002 to 2009 at countries’ offi cial request to WHO. These requests were motivated by sub-regional initiatives, collaborative projects for a situation analysis, and/or countries’ willingness to strengthen national regulatory systems. Assessments included in this report were performed in 26 African countries. Four countries were visited twice; in these cases the most recent fi ndings were taken into account.

The assessments were conducted by teams composed of WHO experts, staff from NMRAs and/or external consultants, acknowledged at the beginning of this report.

Written terms of reference and an agenda for the visits were agreed beforehand with the regulatory authority being assessed. The duration of the visits varied depending on the complexity of the country’s regulatory functions, most visits took approximately three to fi ve working days.

Data were collected by interviewing personnel, reviewing documents (manuals, records, reports, fi les), analysing

data and/or observing activities. Findings were recorded on a comprehensive data collection tool developed by WHO [4], which was later complemented by a detailed guidance document [5]. A draft report was submitted to the regulatory authority after the visit together with a draft plan of action, and comments were invited.

This summary report was produced mainly on the basis of the reports provided to the NMRAs assessed. The completed data collection tools were consulted to verify and complete the fi ndings where necessary.

In order to respect countries’ confi dentiality rights, countries are identifi ed only by randomly assigned numbers in Sections 3.2 - 3.10 and in Annexes 2 -10. Countries are grouped into four geographic sub-regions of Africa (East, West, Middle, South1); Sudan as the only country of the North region has been included in the East region. Sub-units of NMRAs are uniformly referred to as departments, sub-units of countries are referred to as regions.

Limitations

The assessments included in this report took place over a period of eight years. The already comprehensive data collection tool developed by WHO was completed and updated during this time, introducing some variation in the indicators investigated.

The main aim of the visits, and the design of the tool itself, were geared towards identifying priorities for strengthening regulatory capacity. They were not primarily intended to provide comparable indicators of regulatory capacity over time. Not all questions were therefore answered in equal detail for all the countries.

The strengths and weaknesses identifi ed by the authors of the country reports, on which this report is mainly based, refl ect their technical judgement and the views expressed by the regulatory offi cials interviewed.

The evaluation visits were relatively short. Nonetheless, it is thought that the assessors identifi ed the most important issues affecting medicines regulation in each country.

This report presents the situation at the time of the visits. With a few exceptions clearly marked as such, subsequent changes are not refl ected.

1 Source of classifi cation into subregions: Population Division

of the Department of Economic and Social Affairs of the United

Nations Secretariat (2009), World Population Prospects:

The 2008 Revision, http://esa.un.org/unpp.



Results3.

Country profiles3.1

The 26 countries included in this report constituted 88% of the population of sub-Saharan Africa in 2007. Some key economic and health-related data are summarized below, together with corresponding data for OECD countries around the world. Details are shown in Annex 1.

ECONOMIC INDICATORS

Indicator 26 African countries

OECD countries2

Per capita Gross Domestic Product at average exchange rate (US-$, 2006) *

115 (Burundi) – 7 800 (Gabon)Median: 611

7 333 (Turkey) – 89 123 (Luxembourg)Median: 36 714

Per capita total expenditure on health at average exchange rate (US-$, 2006)

7 (Ethiopia) – 425 (South Africa) Median: 32

352 (Turkey) - 6 719 (USA)Median: 3 317

External resources for health as % of total health expenditure (2006)

1 (South Africa) - 60.3 (Mozambique)Median: 22

0

Out-of-pocket expenditure for health, as % of total health expenditure (2006)**

6 (Botswana) -75 (Cameroon)Median: 39

6 (Netherlands) – 52 (Mexico)Median: 17

* Calculated as: Per capita total expenditure on health at average

exchange rate (US$) / Total expenditure on health as proportion of

gross domestic product. Not shown in Annex 1.

** Calculated as: Private expenditure on health as proportion of total

expenditure on health × Out-of-Pocket expenditure as proportion of

private expenditure on health.

Source: WHO World Health Statistics 2009 [6]

In African countries:

Limited resources were refl ected in very low per •

capita expenditures on health (median: 32 US-$ per inhabitant per year);

Donor dependence was high (median: 22% of health •

expenditure); and

Out-of-pocket expenditure by patients was high •

(up to 75% of health expenditure; median: 39%). A large part of out-of-pocket expenditure for health is generally used for medicines [7].

2 Australia, Austria, Belgium, Canada, Czech Republic, Denmark,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

Japan, Korea, Luxembourg, Mexico, the Netherlands, New Zea-

land, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden,

Switzerland, Turkey, United Kingdom, United States.

HEALTH INDICATORS

Indicator 26 African countries

OECD countries

Life expectancy

(years)

46 (Chad, Zambia) –59 (Gabon, Senegal)Median: 52

73 (Hungary, Turkey) –83 (Japan)Median: 80

Neonatal mortality rate (per 1000 live births, 2004)*

17 (South Africa) – 64 (C. Ivoire) Median: 41

1 (Iceland, Japan) – 16 (Turkey)Median: 3

Prevalence of tuberculosis (per 100 000 population, 2007)*

135 (Benin) – 1 104 (Djibouti)Median: 447

3 (Iceland, USA) – 126 (Korea)Median: 9

Prevalence of HIV among adults aged ≥ 15 years (per 100 000 population)*

757 (Niger) – 22 757 (Botswana)

Median: 2 878

9 (Japan) –452 (USA)Median: 125

Percent of years of life lost due to communicable diseases (2004)*

57 (Sudan) –87 (Malawi)Median: 81

3 (Hungary) –26 (Turkey)Median: 5

* Not shown in Annex 1

Source: WHO World Health Statistics 2009 [6]

African countries had a high burden of illness and •

death due to infectious and communicable diseases. Safe, effi cacious, good quality medicines exist to treat these diseases, but health benefi ts will be achieved only if good quality products are made available and used appropriately.

PHARMACEUTICAL SECTOR

IndicatorIndicator 26 African countries (data from country 26 African countries (data from country reports)reports)

Manufacturers Manufacturers > 20 in fi ve countries: Ghana, Kenya, > 20 in fi ve countries: Ghana, Kenya, Nigeria, South AfricaNigeria, South Africa

Distributors Distributors 9 (Djibouti) – 296 (Sudan), private and 9 (Djibouti) – 296 (Sudan), private and public sectorpublic sector

Retail Retail pharmacies pharmacies

9, also acting as distributors (Djibouti) - 9, also acting as distributors (Djibouti) - 1600 registered pharmacies and many other 1600 registered pharmacies and many other outlets (Nigeria), outlets (Nigeria), 1186 pharmacies and 9814 other licensed 1186 pharmacies and 9814 other licensed outlets (Ghana)outlets (Ghana)

The pharmaceutical sector data included in country reports indicated that African countries generally had:

Limited pharmaceutical production capacity, most •

depended mainly on imports.

Some pharmaceutical manufacturing activity catering •

mainly for the domestic and regional demand; however there were some exporting countries; and

A diverse distribution chain, with some types of •

unauthorized outlets suggesting the presence of an informal market (see Annex 1).




The situation in African countries

Most of the African countries included in this report have very limited health budgets, and limited resources for medicines regulation. There are indications of the presence of parallel, unregulated medicines markets, posing serious risks for individual and public health.

Nevertheless, differences exist in the effi ciency of the regulatory measures implemented by countries, illustrating the impact of political commitment and resources allocated to medicines regulation.

In all countries, the challenge remains to maintain comprehensive, effective regulatory systems in a context of rapidly evolving pharmaceutical technologies and an increasingly globalized market.

Regulatory framework3.2

Legislation

Written laws, Acts or Statutes enacted by Parliament give the NMRA the power to control medicines. Regulations prepared under the authority of an Act (the “Enabling Act”) provide details of how regulatory functions are to be carried out. Based on the legislation, guidelines are needed to interpret the legislation and to advise on how to comply with a regulation.

The legal framework should allow effective implementation and provide adequate powers to the NMRA. Legislation should cover all products for which medicinal claims are made, as well as related manufacture and trade activities, in the public and private sectors. Countries should update their medicines legislation and regulations regularly to refl ect national realities and to address new pharmaceutical issues as they arise [1].

KEY FINDINGS (SEE ANNEX 2 FOR DETAILS)

In most countries, legislation had evolved over many + years. The enabling act for medicines regulation was enacted later than 2000 in only three countries.

In many countries, the way in which the legal and − explanatory texts were drafted affected the effi ciency of medicines regulation. Successive regulations and decrees created a complex legal framework with overlaps and grey areas.

Regulations for specifi c regulatory functions were − missing in some countries, especially where a transformation process of the NMRA was taking place.

Regulatory scope

In the last few decades, expansion of the regulatory scope has been considered in many countries [8]. A medicine has been defi ned as “Any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefi t of the recipient” [9]. In addition to conventional medicines for human use, this defi nition also includes biological medicines (including vaccines and blood products), veterinary medicines, and traditional and herbal medicines, although the latter category is challenging to defi ne and to regulate [10].

All types of medicines should be regulated by the NMRA. At the same time, implementation of medicines regulation should not be compromised by other, non-regulatory activities performed by the NMRA. [8]


Seventeen of 26 NMRAs (65%) had the mandate + to control veterinary medicines. In four countries veterinary medicines were controlled by another Ministry, such as the Ministry of Agriculture or Livestock.

Eighteen of 26 NMRAs (69%) had some policy + or provisions to deal with traditional or herbal medicines, eleven of these registered traditional or herbal medicines, another two3 were about to start doing so.

NMRAs in eleven countries− 4 (42%) regulated a wide scope of products, which included foods, poisons, pesticides, bottled water, cosmetics and/or animal food supplements.

In seven countries− 5, the NMRA was involved in designing and implementing national medicines strategies, implementing legislation or coordinating public sector medicines supply; in one case a clearly distinguished unit was in charge of policy issues.

Organizational forms

The choice of a specifi c organizational form will have an impact on the autonomy, visibility and accountability of an NMRA. These factors can in turn affect the organization’s effi ciency in medicines control.

3 Country 02, Country 16 (no regulations yet)

4 Countries 02, 03, 04, 11, 12, 14, 16, 19, 23, 24, 26

5 Countries 01, 09, 13, 17, 18, 22, 23; in Country 15 policy

activities and regulatory functions were carried out by different

organizational units of the NMRA


10 A n o v e r v i e w o f f i n d i n g s f r o m 2 6 a s s e s s m e n t r e p o r t s1

One central authority should be accountable for the overall effectiveness of medicines regulation. It should have the legal power from government to acquire and use resources, recruit and dismiss staff, and make independent decisions.

KEY FINDINGS (SEE FIGURE 2AND ANNEX 2 FOR DETAILS)

Historically, most NMRAs in Africa started out as departments under the Ministry of Health. Organizations of this type have little autonomy. They cannot recruit their own staff, nor can they offer adequate salaries to attract and retain qualifi ed experts. With the maturation of regulatory systems, some countries are moving away from this model, and are establishing their NMRAs as autonomous bodies or as centralized parastatal agencies with their own management structures.

Seventeen of 26 authorities (65%) were departments •

of the Ministry of Health, with very little or no autonomy to manage their own funds and human resources.

Seven NMRAs (27%, • including four departments of MoH and two autonomous bodies) were in transition or not formally constituted at the time of the visit.

FIGURE 2: LEGAL FORMS OF NMRAS AT TIME OF VISIT

Department of MoH

Autonomous body

Parastatal agency

4

5

17

Regulatory functions

The responsibilities assumed by the authority should cover all medicines regulatory functions and should be performed in a balanced fashion.

If functions are distributed between different authorities, either horizontally (e.g. ministry of health, ministry of agriculture) or vertically (federal, state/regional and local governments), a central coordinating body should be accountable for all aspects of medicines regulation in the country [1].

KEY FINDINGS (SEE FIGURES 3A AND 3B, AND ANNEX 2 FOR DETAILS)

Four of the 26 NMRAs (15%) had all fi ve main + functions shown in Figure 3B (marketing authorization, licensing, inspection, quality control and pharmacovigilance) under their umbrella.

Seventeen NMRAs (65%) had access to a functional + national regulatory QC laboratory, seven of these laboratories were part of the NMRA. In one of the remaining countries, there was an NMRA lab which had ceased to function several years earlier.

Most countries had fragmented regulatory systems. − Gaps and overlaps of responsibilities were common, especially in licensing (involving the Ministry of Public Health or Ministry of Trade) and inspection (involving Pharmaceutical Councils, regional authorities or public health inspectorates).

Decentralization and cooperation between authorities − was problematic; 12 reports highlighted the lack of communication at operational level.

In many cases, regulatory functions were not − operational and in some cases not even delegated by law to the national medicines regulatory authority.




FIGURE 3B: COMBINATIONS OF FUNCTIONS WHOLLY OR PARTLY UNDER THE UMBRELLA OF NMRAS

Number of main functions per for med by NMRA*

Marketing authori zation

Licensing Inspection Quality control

Pharmaco-vigilance

Number of NMRAs

5 / 5 4

4 / 5 9

3

1

3 / 5 1

3

1

2 / 5 1

1

1 / 5 1

0 / 5 (NMRA not yet established) 1

Total 26

* Including functions performed jointly with one or more other authorities

Num

ber

of N

MRA

s

Done by NMRA

Done by other body

Not assigned

Done by NMRA+other

Assigned to NMRA but not done

25

20

15

10

5

0

Mar

ketin

g

auth

oriz.

Licen

sing

Insp

ectio

n

Quality

contro

l

Pharm

aco-

vigila

nce

Control o

f

prom

otion

Control o

f

clin. t

rials

FIGURE 3A: PERFORMANCE OF REGULATORY FUNCTIONS



Structure and management3.3

Funding

Sustainable funding for NMRAs should be derived from various sources:

1. Fees, which should contribute signifi cantly to operational costs but should not discourage applications,

2. Public funding, to make NMRAs less dependent of the parties which they are mandated to regulate, and

3. Donations to supplement limited public funds.

NMRAs should have the autonomy to retain the fees collected for services provided, and to use them for their own purpose.


Most NMRAs derived their funding from more than + one source, although the proportions varied from one country to another.

Fees were commonly charged for initial marketing + authorization, renewal and retention. More rarely, fees were charged for importation of medicines, inspection, analysis of samples and registering persons and premises.

Generally, the fees were lower than the cost of services − rendered, and were not retained or redistributed in full.

At the time of the visits, nine NMRAs depended on − government funding, with all fees paid directly to the treasury and not redistributed. Four of these also received donor funding. Funds allocated to the NMRAs by the respective States were not always released on time.

None of the NMRAs assessed had adequate and − sustained funding for its operations.

Human resource management

Personnel engaged in medicines regulation should be individuals of integrity and appropriately trained and qualifi ed. Human resources development programmes should be made available to enable staff to keep up with developments in pharmaceutical science and technology [8].


In general, human resource management was either non-existent or, where it existed, ineffi cient. This was the case especially where the NMRA was at a low level of hierarchy within the Ministry of Health. As a result, lack of qualifi ed staff affected critical regulatory functions (see Sections 3.4, Marketing authorization, and 3.7, Inspections). Specifi c shortcomings included the following:

Only two of the 26 NMRAs (8%) had a human resource − development plan, which was however not specifi c to the tasks of the NMRA. Specifi c training needs and diffi cult access to sources of current information were noted in most countries.

Job descriptions for key personnel were described as − absent in fi ve countries, and as unclear or outdated in four. Four reports mentioned the absence of an organigram.

In some authorities, responsibilities were not assigned − appropriately. One NMRA director was at the same time the director of the national laboratory, resulting in an unmanageable workload. Three others6 were simultaneously in charge of public sector medicines supply or tenders, creating apotential confl ict of interest.

Five reports− 7 mentioned the absence of a legal advisor on the NMRA’s payroll.

Quality management system

NMRAs perform critical and sensitive functions such handling and assessing marketing application dossiers containing confi dential information, inspecting facilities and handling site master fi les.

A quality management system (QMS) should ensure that the operations of an NMRA are carried out to defi ned, uniform standards, and that each step of the regulatory processes is identifi ed and documented.

6 Countries 13, 20 and 21

7 Countries 02, 12, 17, 18 and 23




FIGURE 4: PRESENCE OF QUALITY MANAGEMENT SYSTEMS (QMS) AT NMRAS

NMRA not established

Not described in report

No QMS

Being drafted

Partially implemented

2

6

4

12

2

(see Annex 3 for details)

KEY FINDINGS (SEE FIGURE 4 ANDANNEX 3 FOR DETAILS)

Four NMRAs (15%) were in the process of + implementing a QMS and had elements of the system in place, two others were drafting a system.

None of the NMRAs had implemented a comprehensive − QMS.

IMPARTIALITY AND TRANSPARENCY

Medicines regulation is a public policy that restricts private sector activities in order to attain social goals – the promotion of public health - set by the State. Confl icting interests therefore need to be recognized and managed appropriately.

To provide credible regulatory services, NMRAs must have specifi c measures in place to avoid confl ict of interest in decision-making, to ensure confi dentiality, to make their rules and decisions transparent, and to consult with stakeholders.


Nine of the 26 NMRAs had set up websites at the time + of the visits. Five of these were in need of updating, one had links which were not functioning correctly. As at November 2009, fi ve additional sites were identifi ed, one of the initial nine could no longer be found [11].

Consultation with stakeholders took place in most + countries, although it tended to be limited to specifi c issues (e.g. regulations) or groups (e.g. professional associations).

Current information was not always publicly available: − lists of approved products or establishments were often missing and/or outdated. Little information was made public on decision-making.

Twenty-three− 8 of 26 NMRAs (88%) had no written declarations of interest and confi dentiality agreements in place, although some had general rules of conduct such as a code for civil servants. In the three countries which did have a specifi c written system, this did not apply to all technical staff involved in regulatory functions.

Medicines registration 3.4 (marketing authorization)

Authorization of medicines for sale in a country, based on a scientifi c assessment of their safety, effi cacy and quality, could be considered as the core regulatory function.

To assess applications for marketing authorization, NMRAs need the following:

1. Legal basis, giving the NMRA the power to grant, renew, vary, suspend and withdraw of marketing authorization

2. Guidelines for applicants, setting out the conditions, content and format of applications, AND the detailed technical requirements against which dossiers will be assessed, based on international guidelines [e.g. 12, 13, 14]

3. Standardized operating procedures to assess the submissions, and standard formats to communicate and publish the outcomes

4. Expert assessors in adequate numbers and with specifi c, current expertise

5. Logistics for management, secure storage, retrieval and exchange of data with other regulatory departments, as well access to current scientifi c and technical information

6. Mechanisms to consider other, stringent NMRAs’ decisions

KEY FINDINGS (SEE FIGURE 5 AND ANNEX 4 FOR DETAILS)

Some evaluation of technical documents was + performed in 19 of 26 countries (73%) to varying degrees of stringency at least for generic medicines.

Although the aim of the visits was to identify critical − gaps (not to document the consistency of the technical

8 All except Countries 11, 15 and 26



evaluation process with WHO guidance), it can be concluded that the technical standard of evaluations was generally not in line with WHO standards. The reports from four countries9 mentioned that guidelines did not require proof of bioequivalence for generics. At least three NMRAs10 did not require the manufacturer to have GMP certifi cation. At least six NMRAs11 did not assess summaries of product characteristics (SPC).

The capacity to assess applications for new innovator − products was almost non-existent in most countries; one country relied exclusively on well-qualifi ed external assessors, but organizational issues caused delays in assessments.

NMRAs in seven countries conducted either only an − administrative review of documents or no review at all at the time of the visit.

FIGURE 5: PROCESSES IN PLACE FOR GRANTING MARKETING AUTHORIZATION FOR MEDICINES

System not yet established

No process ongoing at time of visit

MA granted without evaluation

Administrative review of documents

Evaluation of technical documents

Process for granting MA

Num

ber

of N

MRA

s

25

20

15

10

5

0

1. Legal basis and regulations

Eighteen of 26 NMRAs (69%) operated on a legal + basis which empowered them to assess applications for marketing authorization, with regulations that briefl y outlined the requirements or listed the components of dossiers to be submitted for different types of products.

Provisions for renewal of marketing authorizations + were in place, usually after 5 years.

Seven countries had provisions which exempted wide − ranges of products (such as public sector imports

9 Countries 05, 09, 20 and 25

10 The reports state that GMP was verifi ed in Countries 02, 11 and

05 (in the latter country the system was not yet functional); and

that it was not required in Countries 04, 16 and 18.

11 Seven reports stated that SPC were not being assessed (countries

02, 03, 04, 13, 14, 22 and 24). Where SPC were assessed, they

were not necessarily published as part of marketing authoriza-

tion (see also Annex 4).

or donations) from registration or from specifi c requirements irrespective of quality risk. For example, in one country, all oral solid-dose anti-infectives were exempt from in vivo bioequivalence studies, regardless of their biopharmaceutical classifi cation.

2. Guidelines

The aim of the visits was not to verify compliance with WHO guidance systematically, but rather to assess the adequacy of national guidelines and to identify gaps. Some countries had guidelines which described the required content of submissions and gave brief instructions, but did not give suffi cient guidance on technical issues such as bioequivalence and stability. Others described only the administrative steps, yet others provided only checklists. A specifi c format for submissions was not required in any of the countries.

Only three NMRAs (12%) provided detailed technical − guidelines, although this did not necessarily mean that they were in line with all applicable WHO guidance.

3. Procedures for assessment

Written standard operating procedures for dossier assessment were either absent altogether, or they described only administrative steps such as checking the completeness of dossiers, payment of fees or inclusion of samples, or they were checklists of the elements of the assessment methodology.

Adequate SOPs for dossier assessment were in place − in only three countries.

Timeframes for assessment of applications ranged from 3 months to 5 years, depending on the complexity of assessments and available resources. Fast-track mechanisms existed for certain needed product types.

Although overall assessment time frames were long, − little time was available for a thorough in-depth assessment by experts due to scheduling diffi culties and backlogs.

4. Expert assessors

Most NMRAs had formal advisory committees. However, not all committees were operational, bringing assessment to a halt in two countries. Eleven countries used external experts, two of them exclusively. Appointment of committee members and experts was not necessarily based on specifi c regulatory expertise, and provisions for confi dentiality and declaration of interest were lacking in most countries (see also Annex 3). Two




reports12 mentioned the short preparation and meeting times available for committee members to make their decisions, meaning that they may not be able to read all documents and carry out any real assessment.

Twenty-four of 26 country reports (92%) mentioned − the shortage of adequately qualifi ed assessors as an obstacle to timely dossier evaluation.

5. Logistics

Only four NMRAs (15%) had appropriate archiving − space to store confi dential data securely.

Only six of 26 countries (23%) had coherent, − networked computerized systems designed for medicines registration in place. Nine (35%) had only manual systems.

The latter shortcoming affected transparency and information-sharing with other departments. Lists of registered products were not readily available, which made it diffi cult to verify the registration status of medicines circulating in the market and those being imported. The countries which did publish a list did not include the approved summaries of product characteristics (SPC), needed to verify package inserts, information for health professionals and advertising claims.

12 Countries 03 and 26

6. Recognition of other NMRA's decisions

Certifi cates of pharmaceutical products (CPPs) issued under the provisions of WHO Certifi cation Scheme on the quality of pharmaceutical products moving in international commerce [15] were commonly requested as part of applications, but usually without considering the capacity of the issuing regulatory authority to certify that the data on the certifi cates were correct. Conversely, one report from an exporting country13 mentioned that the NMRA “issues CPP without ascertaining that all prerequisites as specifi ed by WHO are fulfi lled”.

Only two NMRAs (8%) explicitly relied on other − regulatory bodies/organizations which they considered stringent, including the WHO Prequalifi cation Programme [16] in one case.

The lack of mechanisms and procedures that would enable NMRAs to benefi t from the scientifi c assessments and inspections carried out by other well resourced and established regulators is a major cause of concern, as most of the authorities in the region have limited human resources and scientifi c expertise.

13 Country 24

Num

ber

of N

MRA

s

25

20

15

10

5

0

Adequate Existing but inadequate Not existing Not mentioned in country report

Guidelines

(tech. detail) SOPs for

assessment Assessors

Legal basis

(outline)Secure filin

g

space IT system

FIGURE 6: RESOURCES FOR MEDICINES REGISTRATION



Licensing of activities3.5

Licensing of pharmaceutical establishments

As can be seen from the country profi les, health budgets in African countries are low, high percentages of health costs are paid out of pocket, and there are many types of medicines outlets not managed by a pharmacist. Concerns about the parallel medicines market were voiced in most reports, such as this typical statement14: “The illicit medicines market has become a real plague in [the country]. All therapeutic classes can be found, including psychotropic medicines, and there is no national strategy to combat this situation”.

A mandatory system of licensing manufacturers, wholesalers/distributors and retailers is essential to ensure that medicines conform to acceptable standards of quality, safety and effi cacy until they reach the end user. Licensing must be complemented by inspections (see Section 3.7) and market surveillance (see Section 3.9) to monitor and enforce compliance.

NMRAs should ensure that all premises and practices used to manufacture, store, distribute and dispense pharmaceutical products comply with current guidelines on Good Manufacturing Practice [17], Good Storage Practice [18] Good Distribution Practice [19] and Good Pharmacy Practice (GPP) [20].

KEY FINDINGS (SEE ANNEX 5)

All countries except one had systems in place to + license pharmaceutical establishments.

GMP was not required in at least 9 countries− 15. In at least two countries where GMP was required16, none of the established manufacturers had GMP certifi cation.

Only fi ve of 26 countries (20% - see Annex 7) had − published GMP guidelines meeting WHO standards (two had national texts, and another three used the WHO text). Only one country (4%) had adequate GDP guidelines.

Authorities other than the NMRA were involved in − licensing in 16 countries (62%), resulting in overlaps, grey areas and gaps in the control of pharmaceutical activities.

14 Country 17

15 Countries 03, 06, 08, 09, 12, 14, 17, 24 and 25

16 Countries 02 and 05

Decentralization of licensing, involving regional − authorities, was not organized effi ciently. Lack of coordination between departments and with enforcement agencies was commonly highlighted.

Licences or renewals were granted without inspection − in some instances.

In practice the requirements for Good Manufacturing − Practice, Good Distribution Practice and Good Pharmacy Practice were poorly enforced. For example, In one country17 only a single one of many established manufacturers was licensed.

Import and export control3.6

A system to grant marketing authorization for pharmaceutical products is not in itself a suffi cient mechanism to control the quality of products circulating in the country. It should be complemented by a range of other control measures (see also Figure 1), including the authorization of each import act of pharmaceutical products.

Each act of importation should be subject to authorization by the NMRA on the basis of the product’s registration (marketing authorization) status.

Products for export should be subject to the same standards as those for domestic consumption.


Control of imported products was weak. In at least − eight countries18 (31%) there was no effi cient system to verify the marketing authorization status and exemptions for imported products.

Cooperation with police and customs was consistently − described as problematic.

Mechanisms to control exported medicines were − either absent or not stringently enforced. One report19 mentioned manufacturers’ illegal practice of issuing “free sale certifi cates”, which leaves all control to the receiving country.

17 Country 04

18 Countries 07, 09, 13, 18, 22, 23, 24 and 25

19 Country 02




Inspections 3.7

Inspection of pharmaceutical facilities should enable medicines regulatory authorities to monitor whether pharmaceutical activities are carried out in accordance with approved standards and guidelines. The effi ciency of inspections has a direct impact on the extent to which medicines control is enforced.

A legal basis must be in place for inspections and enforcement of compliance with relevant good practices. Routine inspections should be planned and implemented to verify this compliance regularly.

A quality management system [21] should ensure that inspections are planned, conducted, documented and followed up in a consistent way, based on risk assessment.

Enough qualifi ed inspectors and suffi cient logistic resources must be available to cover the geographic area to be regulated.

KEY FINDINGS (SEE FIGURE 7 ANDANNEX 7 FOR DETAILS)

A legal basis empowering the relevant authority to + perform inspections was in place in 17 countries.

SOPs for inspection, if any, were mostly in checklist − format and were not comprehensive.

No NMRA had a comprehensive quality management − and planning system for inspections in place.

Shortages of qualifi ed inspectors were a universal − problem. The need for specifi c training of inspectors in current GMP was commonly highlighted.

Potential confl icts of interest were noted in at least − three countries20.

Inadequate logistic resources, especially means − of transport and communication, were a major constraint.

The effectiveness of inspections suffered from these constraints.

20 In Countries 02 and 05 the inspectors were also permitted to

be supervisors/technical directors of pharmacies. In Country 03

pharmacists from distribution channels and manufacturers were

used as inspectors

Num

ber

of N

MRA

s

25

20

15

10

5

0

Adequate Existing but inadequate Not existing No information or not applicable

Legal basis

Published

GMP textSOPs

QMS

InspectorsLogistic

s

FIGURE 7: RESOURCES FOR INSPECTIONS



Quality control3.8

Quality control (QC) aims to verify that products comply with the specifi cations of the marketing authorization. Even if pre-marketing samples meet defi ned standards, the same quality standards may not be met by each batch of product put on the market. QC testing of post-marketing samples thus acts as a deterrent against negligent or fraudulent manufacturing and trading practices [8].

NMRAs should have access to a quality control laboratory with adequate capacity to undertake quality surveillance.

QC facilities must have enough qualifi ed personnel and the necessary equipment and materials, and must operate according to established standards [8]. A Quality Management System (QMS), such as ISO 17025 [22], provides a framework for QC laboratories to operate according to defi ned procedures and standards. WHO’s guidance on Good Laboratory Practice [23, 24] provides detailed advice on organizational and technical issues.

If dossiers are assessed and samples tested, good collaboration between assessors and laboratory staff needs to be in place.


A QMS was in place at fi ve (29%) of the 17 functioning + regulatory laboratories; three others had partial systems which were lacking essential elements and were not fully operational.

Satisfactory staffi ng and equipment were in place + in the majority of cases, but six laboratories were housed in inadequate buildings.

Ten reports mentioned QC testing for pre-marketing applications. However, the laboratories were not always given the relevant dossiers, manufacturer’s reference materials and validated methods.

Market surveillance 3.9 (product quality monitoring, pharmacovigilance, control of promotion and advertising)

Product quality monitoring

Substandard pharmaceuticals may circulate in the market if good practices in manufacturing, distribution and storage are not adhered to.

In addition, counterfeiting – the production and distribution of medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source - is becoming an increasing problem. It requires a coordinated response from different sectors both at country level and internationally [25].

In both cases, the defi cient products pose a risk for individual and public health.

A risk-based system of inspections and sampling should be in place to monitor the quality of pharmaceutical products on the market. Manufacturers should be obliged to report complaints and quality problems to the NMRA. An effective recall procedure should be in place to remove defective products from the market.

The NMRA should coordinate an anti-counterfeiting programme with all concerned parties, including industry, customs, police and any other stakeholders involved in trade or distribution of pharmaceuticals.

FIGURE 8: QUALITY CONTROL TESTING

Num

ber

of N

MRA

s

25

20

15

10

5

0

Yes Partial None No information No functioning regulatory laboratory

Adequate

equipmentQC Lab

has QMS Adequate

staff





Fourteen of 26 NMRAs (54%) lacked a quality − monitoring programme altogether; 7 tested samples in case of complaints or in the framework of specifi c programmes, and only 5 (19%) had a systematic approach.

Twenty of 26 NMRAs (77%) lacked a written procedure to − organize an effective recall, of the existing six procedures three needed clarifi cation. Five reports21 noted the lack of batch traceability needed to recall products. This fi nding is consistent with the general absence of published GDP guidelines mentioned in Section 4.5.

Anti-counterfeiting measures included inspections − and surveillance in fi ve countries and awareness programmes in three. No country had a specifi c, comprehensive programme in place at the time of the visits.

Pharmacovigilance (monitoring of adverse reactions to medicines)

Pre-marketing clinical trials are usually conducted on a small numbers of volunteers, who may not always be representative of the target population for whom the medicine is intended. Not all adverse reactions can be anticipated from these studies.

NMRAs should implement a system to monitor adverse events. For this to be effective, there must be a high probability for adverse events to be identifi ed and reported, reports must be reviewed and validated by experts, results must be fed back, and appropriate regulatory action must be taken [8].

21 Countries 09, 14, 18, 20; Country 25 (no traceability of free

samples distributed to patients and doctors)


Eight of 26 countries collected reports on adverse + events, with three of the programmes being suffi ciently established to contribute a sizeable number of results. Seven of the 8 countries were members of the WHO Programme for International Drug Monitoring(see http://www.who-umc.org/).

Where it existed, pharmacovigilance was generally + not well integrated with other regulatory activities or with clinical surveillance measures implemented by specifi c national or NGO treatment programmes.

Control of medicine promotion and advertising, provision of drug information

Information propagated through promotion and advertising can signifi cantly infl uence the way in which medicines are prescribed by health professionals and used by consumers. Inaccurate and misleading information therefore poses a health risk [8].

NMRAs should control promotion and advertising to ensure that any claims made correspond to the approved summary of product characteristics (SPC). They should also provide independent information on medicines to the public and health professionals [1].


Most countries had some legal provisions for the + control of medicines promotion. Seven of 26 countries (27%) controlled pharmaceutical promotion to varying extents.

In 19 countries (73%) there was no control of − promotion and advertising in practice, meaning that even if the regulations were in place, they were not implemented.

At least 13 NMRAs did not provide any independent − medicines information to the public.

FIGURE 9: MARKET CONTROL MECHANISMS

Num

ber

of N

MRA

s

25

20

15

10

5

0

Yes Exists, inadequate No No information

Quality

monitoring Anti-c'feiting

programme Recall

procedure Pharmaco-

vigilance Control of

promotion



Oversight of clinical trials3.10

Clinical trials are an essential component of pharmaceutical research and development. They serve to establish the safety and effi cacy of new medicines, and to develop new treatment uses of well known medicines. Clinical trials also include in vivo bioequivalence studies carried out with generic medicines to establish their therapeutic interchangeability with originator products. In all these types of studies the ethical rights and the safety of trial subjects must be protected, and the methodology must be designed in such a way as to arrive at useful, scientifi cally valid results.

NMRAs should control clinical trials jointly with external bodies such as national or institutional ethics committees.

Trials should conform with ethical principles for medical research involving human subjects (the Declaration of Helsinki [26]). Guidelines by the Council of International Organization of Medical Sciences (CIOMS)22 provide valuable additional information on research ethics.

WHO guidelines for GCP [27] and GLP [23] should be followed. GMP of investigational products should be verifi ed. Other more specifi c guidelines on clinical research may apply.

Trials should be monitored for compliance with all applicable guidelines. Investigators should be required to report on the outcomes promptly, including any serious adverse events encountered.

22 www.cioms.ch

KEY FINDINGS (SEE FIGURE 10AND ANNEX 10 FOR DETAILS)

In 18 of 26 countries (69%) clinical trials were + controlled to some extent, mostly with regard to ethical aspects.

Where ethics committees were involved, NMRAs − retained little or no control due to lack of capacity, unclear assignment of responsibilities or non-representation in the relevant committees.

Adherence to GLP and GCP was not a requirement − in 22 countries (85%); detailed GCP guidelines were found in only two countries (8%).

Eight reports mentioned the absence of import − controls and GMP requirements for investigational products.

Only four country reports mentioned that inspections − of clinical trials were being conducted.




Conclusions4.

The countries included in this report had legal provisions for most essential aspects of medicines control. However, their regulatory systems presented some critical weaknesses. The legal framework had evolved over time, resulting in a fragmentation of responsibilities with gaps and grey areas, and a multitude of provisions which were diffi cult to implement. Many NMRAs had little power and autonomy, and oversaw a limited range of regulatory functions with little accountability or managerial commitment. In almost all countries visited, lack of sustainable funding restricted the regulatory operations. Virtually all NMRAs suffered from staff shortages. For the most part, assessors and inspectors were not at the level of current scientifi c and technical expertise needed for their regulatory tasks. Regulatory requirements and processes were not in line with recommended WHO standards.

As a result, medicines regulation was not carried out to the full extent required to ensure the quality, effi cacy and safety of medicines in African countries. The fi ndings confi rm the results of a 2004 questionnaire survey conducted by WHO in 38 African member states, which found that 90% of countries did not provide or enforce adequate regulatory functions [28].

Despite the universally scarce resources and the health workforce crisis experienced throughout sub-Saharan Africa [29], the effi ciency of medicines control varied among countries, showing that political commitment at national level can make a difference.

On the positive side, it was noted that many countries were committed to improve their medicines regulatory capacity: Reviews of the systems were invited, and regulatory structures were being adapted. However, in many cases, the transformation processes created new administrative hurdles which complicated effective decision-making, management and release of funding.

The follow-up assessments conducted in four countries showed that progress in specifi c aspects was achievable. However, the improvements were partial, and were not suffi cient to build sound, well-resourced national medicines regulatory systems.

The way forward should be towards effective implementation of medicines control in practice. Political commitment and substantial human and fi nancial resources will be needed for this purpose. Countries will need to take concerted action if they are to expand access to medicines of assured quality for their populations. The following approaches will be useful to build regulatory capacity in Africa:

Encourage and assist WHO Member States to •

regularly assess their own regulatory systems in a standardized way. The WHO assessment tool [4] and the accompanying guidance [5] have been developed for this purpose.

Consider mechanisms to share the outcomes of •

regulatory assessments.

Work towards effective implementation of all •

essential regulatory functions under the umbrella of NMRAs.

Continuously adapt and update the legal framework •

for medicines regulation in accordance with internationally recognized norms, standards and best practices.

Encourage WHO Member States to grant their NMRAs •

an adequate organizational structure, suffi cient autonomy and sustainable resources to enable them to carry out their operations.

Provide specifi c, relevant training for assessors, •

inspectors and other technical staff, in line with current technical recommendations and good practices.



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es

Uga

nda

Jun

2009

30.8

8424

1 03

848

$24

3138

300

[29]

1785

400

priv

ate

Uni

ted

Rep.

of

Tanz

ania

Jun

2003

40.4

5494

5 98

552

$23

4423

Appr

ox. 6

507+

1 sm

all-

scal

e17

5 (in

cl. 4

0 im

port

ers)

349

phar

mac

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+400

0 ou

tlet

s

Zam

bia

Mar

200

611

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752

614

46$5

838

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6340

Tota

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ast)

:29

6.84

5(8

6%)

SOU

TH55

.682

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wan

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581

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56$3

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Sout

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rica

Sep

2002

48.5

771

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251

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94 lo

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ate

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s, 18

00

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Tota

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outh

):50

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)

23

Sou

rce

of

clas

sifi

cati

on

in

to g

eogra

ph

ic r

egio

ns:

Popu

lati

on

Div

isio

n o

f th

e D

epar

tmen

t of

Econ

om

ic a

nd S

oci

al A

ffai

rs o

f th

e U

nit

ed N

atio

ns

Sec

reta

riat

(2009),

Worl

d P

opu

lati

on

Pro

spec

ts: Th

e 2008 R

evis

ion

,

htt

p:/

/un

stat

s.u

n.o

rg/u

nsd

/met

hods/

m49/m

49re

gin

.htm

#af

rica

. Su

dan

as

the

on

ly c

ou

ntr

y of

the

Nort

h r

egio

n h

as b

een

in

clu

ded

in

th

e Ea

st r

egio

n.

24

Cal

cula

ted a

s: P

riva

te e

xpen

dit

ure

on

hea

lth

as

pro

port

ion

of

tota

l ex

pen

dit

ure

on

hea

lth

× O

ut-

of-

Pock

et e

xpen

dit

ure

as

pro

port

ion

of

pri

vate

exp

endit

ure

on

hea

lth




24

Cal

cula

ted a

s: P

riva

te e

xpen

dit

ure

on

hea

lth

as

pro

port

ion

of

tota

l ex

pen

dit

ure

on

hea

lth

× O

ut-

of-

Pock

et e

xpen

dit

ure

as

pro

port

ion

of

pri

vate

exp

endit

ure

on

hea

lth

Geo

grap

hic

Afri

can

regi

on23

Date

of

visi

t

Popu

lati

on

(mill

ion,

20

07)

[6]

Area

(km

2 )

Life expectancy at birth (years, 2007)

Per capita total ex pen -diture on health at averag e exchange rate (US$, 2006)

External resour ces for health as % of total expend. on health (2006)

Out-Of-Pocket expenditure as % of total expend. on health (2006)24

Phar

mac

ists

Man

u fac

ture

rsD

istr

ibut

ors

Reta

il ou

tlet

s

("Sh

ops"

= o

utle

ts n

ot

unde

r th

e su

perv

isio

n of

a p

harm

acis

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untr

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MID

DLE

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laN

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17.0

241

246

700

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unkn

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475

650

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0

Chad

Sep

2007

10.7

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000

46$2

918

4447

Non

e6

47+u

nkno

wn

num

ber

of s

tock

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DRC

Feb

2008

62.6

362

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052

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tor;

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7 66

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161

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Tota

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286.

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25

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ed)

615

5

Cote

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Sep

2006

19.2

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354

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May

200

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Publ

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2004

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Jan

2007

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9%)

Gra

nd T

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wis

e st

ated

. So

urce

of

clas

sifi c

atio

n in

to s

ubre

gion

s: P

opu

lati

on

Div

isio

n o

f th

e D

epar

tmen

t of

Econ

om

ic a

nd S

oci

al A

ffai

rs o

f th

e U

nit

ed N

atio

ns

Sec

reta

riat

(2009).

Worl

d P

opu

lati

on

Pro

spec

ts: Th

e 2008 R

evis

ion

. htt

p:/

/un

stat

s.u

n.o

rg/u

nsd

/met

hods/

m49/m

49re

gin

.htm

#af

rica

. Su

dan

as

the

on

ly c

ou

ntr

y of

the

Nort

h r

egio

n h

as b

een

in

clu

ded

in

th

e Ea

st r

egio

n.



AN

NE

X 2

: Org

aniz

atio

nal

stru

ctur

e an

d im

plem

enta

tion

of

regu

lato

ry f

unct

ions

= N

MRA

; a

noth

er b

ody,

= tw

o ot

her b

odie

s, =

NM

RA a

nd a

noth

er b

ody,

= N

MRA

and

two

othe

r bod

ies,

= n

ot a

ssig

ned

to a

spe

cifi c

bod

y;

shad

ed: o

pera

tiona

l at t

he ti

me

of th

e vi

sit

Coun

try

Year

of

en-

ablin

g Ac

t

Auth

orit

y an

d le

gal f

orm

:

A:

Gov

ernm

ent

Dep

artm

ent

B:

Aut

onom

ous

body

C:

Par

asta

tal a

genc

y

Mar

keti

ng

auth

oriz

a tio

n (s

ee a

lso

3.4)

Lice

nsin

g &

im

port

con

trol

(s

ee a

lso

3.5)

Insp

ec ti

on (s

ee a

lso

3.7)

Qua

lity

cont

rol

(see

als

o 3.

8)

Phar

mac

o-vi

gila

nce

(see

als

o 3.

9)

Cont

rol o

f pr

omot

ion

(see

als

o 3.

9)

Cont

rol o

f cl

inic

al t

rial

s (s

ee a

lso

3.10

)

Vet

med

sTr

ad./

her-

bal

med

s

EAST 02

1978

Auto

nom

ous

body

,(la

ter

sem

i-au

tono

mou

s ag

ency

) B

Yes

Yes

0319

88Se

mi-

auto

nom

ous

para

stat

al B

oard

C

Min

iste

r on

NM

RA

adv

ice

Yes

No

0419

99

Para

stat

al, a

uton

omou

s bo

dy +

advi

s. bo

ard

(no

tech

nica

l com

mitt

ees)

C

Yes

Yes

0619

99D

epar

tmen

t w

ithi

n M

oH, t

rans

itio

nal

(aw

aiti

ng t

rans

form

atio

n in

to

agen

cy)

A

Yes

No

0719

98D

eleg

ated

to

Phar

m D

ept

MoH

(N

MRA

nev

er f

orm

ally

est

ablis

hed)

A

Oth

er

auth

.N

o

0919

82D

epar

tmen

t w

ithi

n M

oH

(not

offi

cia

lly c

onst

itut

ed)

A

Oth

er

auth

.Ye

s

1020

01D

epar

tmen

t w

ithi

n M

oH(N

MRA

pro

pose

d, n

ot y

et

esta

blis

hed)

A

N

oN

o

1519

63D

epar

tmen

t an

d Se

cret

aria

t in

MoH

on

beh

alf

of a

uton

omou

s Bo

ard

A

Oth

er

auth

.Ye

s re

gist

1620

04Au

tono

mou

s bo

ard

(not

yet

ap

prov

ed a

t ti

me

of v

isit

)B

Ye

sYe

s

2019

57Bo

ard

as b

ody

corp

orat

e (a

ll te

chni

cal s

taff

sec

onde

d by

MoH

)B

Ye

sN

o

26 1

952

Body

cor

pora

te (B

oard

and

Se

cret

aria

t)B

Ye

sYe

s re

gist

SOU

TH

1119

65Ag

ency

, sup

port

ed b

y M

oH(+

prof

essi

onal

cou

ncil)

C

Yes

Yes

2119

92

Med

icin

es re

gula

tory

dep

artm

ent

wit

hin

MoH

(fun

ctio

ns a

nd

resp

onsi

bilit

ies

not

clea

rly s

tate

d in

le

gisl

atio

n)

A

No

No




Coun

try

Year

of

en-

ablin

g Ac

t

Auth

orit

y an

d le

gal f

orm

:

A:

Gov

ernm

ent

Dep

artm

ent

B:

Aut

onom

ous

body

C:

Par

asta

tal a

genc

y

Mar

keti

ng

auth

oriz

a tio

n (s

ee a

lso

3.4)

Lice

nsin

g &

im

port

con

trol

(s

ee a

lso

3.5)

Insp

ec ti

on (s

ee a

lso

3.7)

Qua

lity

cont

rol

(see

als

o 3.

8)

Phar

mac

o-vi

gila

nce

(see

als

o 3.

9)

Cont

rol o

f pr

omot

ion

(see

als

o 3.

9)

Cont

rol o

f cl

inic

al t

rial

s (s

ee a

lso

3.10

)

Vet

med

sTr

ad./

her-

bal

med

s

MID

DLE

0519

92D

epar

tmen

t of

MoH

(p

ropo

sed,

not

yet

impl

emen

ted)

A

Oth

erN

o

0819

90D

epar

tmen

t w

ithi

n M

oHA

N

oYe

s re

gist

1219

3325

19

52,

1982

Dep

artm

ent

wit

hin

MoH

A

Yes

(no

regu

l)

Yes

regi

st

1720

00D

epar

tmen

t w

ithi

n M

oH

A

Ye

sYe

s

2519

61D

epar

tmen

t w

ithi

n M

oHA

Ye

sYe

s re

gist

WES

T

0119

94D

epar

tmen

t w

ithi

n M

oHA

N

oYe

s re

gist

1320

06D

epar

tmen

t w

ithi

n M

oHA

No

No

1419

62,

1994

Dep

artm

ent

wit

hin

MoH

A

Ye

sYe

s

1819

84D

epar

tmen

t w

ithi

n M

oH

A

Ye

sYe

s re

gist

1919

92Bo

ard

unde

r co

ntro

l of

MoH

(+Pr

of. c

ounc

il +S

tand

ards

boa

rd)

C

Ye

sYe

s re

gist

2219

95D

epar

tmen

t w

ithi

n M

inis

try

of P

ublic

H

ealt

hA

Yes

Yes

regi

st

2319

54D

epar

tmen

t w

ithi

n M

oH

A

Ye

sYe

s re

gist

2419

93 P

aras

tata

l age

ncy

(+pr

ofes

sion

al c

ounc

il +e

nfor

cem

ent

agen

cy)

C

Ye

sYe

s re

gist

25

1933 leg

isla

tion

on

th

e pra

ctic

e of

ph

arm

acy

rem

ain

s th

e bas

ic leg

isla

tive

fra

mew

ork

; N

MR

A w

as c

on

stit

ute

d b

y le

gis

lati

on

of

1982.



AN

NE

X 3

: Org

aniz

atio

nal

stru

ctur

e an

d m

anag

emen

t

Regi

onType26

Fund

ing:

Sou

rces

Re

tain

edAd

equa

te,

sus t

aine

d

Qua

lity

Man

age m

ent

Syst

em

Staf

f (t

echn

ical

+a

dmin

)

Hum

an r

esou

rce

(HR)

m

anag

emen

t

Code

of

cond

uct

/ in

tere

sts

Info

rmat

ion,

co

nsul

tati

on w

ith

stak

ehol

ders

Web

-sit

e27G

aps

/ rem

arks

Coun

try

EAST 02

B Pu

blic

, don

or, f

ees

Yes

No

Bein

g dr

afte

d35

+16

Insu

ffi c

ient

Stru

ctur

e no

t do

cum

ente

d. N

o H

R de

velo

pmen

t pl

anN

oSo

me

repo

rts

(exc

ept

fi nan

cial

)**

Goo

d co

nsul

tati

on/

coop

erat

ion

nati

onal

ly

03C

Publ

ic, f

ees,

com

mis

sion

Yes

No

No

Boar

d: 7

5 co

mm

itte

es

No

HR

dev.

plan

. Gap

s in

jo

b de

scrip

tion

sN

oSo

me,

web

site

nee

ds

upda

ting

Ye

s**

*H

eavy

relia

nce

on

dono

r/pr

ojec

t fi n

ance

04C

Publ

ic, f

ees

to g

ov.,

part

ners

No

No

58 +

55

Insu

ffi c

ient

Plan

ning

, job

de

scrip

tion

s, bu

t no

HR

dev.

pla

nN

ot s

peci

fi cRe

port

s av

aila

ble

thro

ugh

Parli

amen

t**

No

tech

nica

l com

mit

-te

es t

o su

ppor

t Bo

ard

06A

Publ

ic, d

onor

Yes

(pro

pose

d)N

o N

oIn

suffi

cie

ntN

o ow

n re

crui

ting

. Tr

aini

ng p

lan

exis

tsN

o In

fo n

ot p

ublic

ly

avai

labl

e**

Und

erre

sour

ced

tran

s-it

iona

l org

aniz

atio

n

07A

Publ

ic, f

ees

to

gove

rnm

ent,

dono

r N

oN

oN

o7

+3

Insu

ffi c

ient

Job

desc

ripti

ons,

no

own

recr

uiti

ngN

oVe

ry li

ttle

; web

site

of

MoH

not

use

dN

oLo

w s

alar

ies;

in

adeq

uate

bui

ldin

gs

09A

Publ

ic, f

ees

to

gove

rnm

ent

No

No

No

7 te

chni

cal

Insu

ffi c

ient

No

HR

dev

plan

, no

job

desc

ripti

ons

No

Info

rmat

ion

not

gene

rally

sha

red

No

No

auto

nom

y,

inad

equa

te b

uild

ings

10A

Fees

, im

port

le vi

es

(pro

pose

d)Ye

sn/

a(N

MRA

not

es

tabl

ishe

d)2

n/a

n/a

n/a

n/a

(No

regu

lato

ry

auth

orit

y)

15A

Publ

ic, f

ees,

dono

rN

ot y

et

(agr

eed)

No

Not

com

pre-

hens

ive

35 (B

oard

) +S

ecr.

No

own

recr

uitm

ent.

Unc

lear

job

desc

ripti

ons;

som

e tr

aini

ng p

lann

ed

Yes

for

ex-

tern

al, +

oath

-ta

king

Som

e co

nsul

tati

on,

no in

fo o

n de

cisi

ons

Yes

Polic

y ce

ntra

lized

but

re

gula

tory

fun

ctio

ns

dece

ntra

lized

16B

Publ

ic, f

ees

Yes

No

No

(Tra

nsi t

iona

l)

Insu

ffi c

ient

No

stra

t. pl

an; l

ack

of

staf

f to

man

age

fi nan

ceN

oN

o w

ebsi

teN

oCr

itic

al p

osit

ion

of D

ir.

Gen

eral

not

fi lle

d

20B

Fees

onl

yYe

sN

o?

(Not

for

in

spec

tion

s)Te

ch st

aff s

e-co

n d ed

by

MoH

No

own

recr

uitin

g: n

o H

R m

anag

emen

t sys

tem

sN

oO

utda

ted

web

site

, di

ffi c

ult

to a

cces

sYe

sRe

gist

rar

in c

harg

e of

pr

ocur

emen

t

26B

Publ

ic (2

0 Bo

ard

mem

bers

onl

y); f

ees

Yes

No

Not

impl

e-m

ente

d of

fi cia

lly

Secr

etar

iat:

68+

55

Ade

quat

e

Job

desc

ripti

ons

(200

1); t

rain

ing

(not

sy

stem

atic

)

Yes

(not

for

ex te

rnal

)

Web

site

: som

e lin

ks t

o fo

rms

not

wor

king

Yes

Secr

etar

iat

shou

ld b

e gi

ven

resp

onsi

bilit

y fo

r da

ily f

unct

ioni

ng

SOU

TH 11C

Publ

ic, f

ees

to

gove

rnm

ent

No.

Fee

s-on

ly s

yste

m

prop

osed

No

22 m

embe

rs,

110

MoH

14

6 ex

tern

al

No

HR

dev

plan

for

M

oH s

taff

, unc

lear

job

desc

ripti

ons

Yes

for

exte

rnal

, gen

co

de f

or M

oH

Info

rmal

co

nsul

tati

on

Adm

inis

trat

ive

info

av

aila

ble

Yes

No

own

staf

f -

exte

rnal

par

t-ti

me

expe

rts

and

MoH

sta

ff

21A

Publ

ic, f

ees

to

gove

rnm

ent

No

No

No

6 +z

ero

Insu

ffi c

ient

Inad

equa

te. N

o ow

n re

crui

ting

. Hig

h tu

rnov

erN

oM

oH w

ebsi

te, g

uide

-lin

es n

ot p

oste

dYe

sLa

ck o

f st

aff

and

fund

ing

a m

ajor

pr

oble

m




turn

over

prob

lem

Regi

on

Type26

Fund

ing:

Sou

rces

Re

tain

edAd

equa

te,

sus t

aine

d

Qua

lity

Man

age m

ent

Syst

em

Staf

f (t

echn

ical

+a

dmin

)

Hum

an r

esou

rce

(HR)

m

anag

emen

t

Code

of

cond

uct

/ in

tere

sts

Info

rmat

ion,

co

nsul

tati

on w

ith

stak

ehol

ders

Web

-sit

e27G

aps

/ rem

arks

Coun

try

MID

DLE

05A

Publ

ic, d

onor

, fee

s pr

opos

edN

oN

o(N

MRA

not

es

tabl

ishe

d)

14 +

16

Insu

ffi c

ient

No

HR

deve

lopm

ent

plan

No

(gen

eral

on

ly)

Litt

le in

form

atio

n-sh

arin

gN

oSt

ruct

ure

not

yet

func

tion

al

08A

Publ

ic, f

ees

to

gove

rnm

ent

Redi

strib

u-ti

on 4

5%N

o22

tec

hnic

al

Nee

d tr

aini

ng

No

HR

deve

lopm

ent

plan

No

NM

RA n

ot u

sing

M

in. P

ublic

Hea

lth

web

site

N

oG

over

nmen

t fu

ndin

g no

t al

way

s re

leas

ed

12A

Publ

ic; f

ees,

dona

tion

sRe

dist

ribu-

tion

25%

No

No

7 te

chni

cal

Insu

ffi c

ient

No

HR

deve

lopm

ent

plan

. No

lega

l sup

port

No

Cons

ulta

tion

on

new

re

gula

tion

s / p

olic

ies

No

Dela

yed

rele

ase

of fu

nds

(exc

ept s

alar

ies)

17A

Publ

ic, d

onor

Redi

strib

u-ti

on 7

0%N

oN

o7

tech

nica

l

Insu

ffi c

ient

No

HR

deve

lopm

ent

plan

. No

lega

l sup

port

No

Cons

ulta

tion

on

new

le

gisl

atio

nN

oTa

sks

of t

echn

ical

co

mm

itte

e no

t de

fi ned

25A

Publ

ic, f

ees

Redi

strib

u-ti

on 4

0%N

oN

o13

tech

nica

l

Insu

ffi c

ient

No

orga

nigr

am, j

ob

de sc

ripti

ons

or H

R de

v pl

an

No

Isol

ated

init

iati

ves

(MA/

indu

stry

)N

oIn

tern

al t

echn

ical

co

mm

itte

e, n

o ru

les

WES

T

01A

Publ

ic, d

onor

No

No

27 +

6

Nee

d tr

aini

ng

No

HR

deve

lopm

ent

plan

No

Som

e co

nsul

tati

on

(pro

f. as

soci

atio

ns)

**Fu

ndin

g no

t re

leas

ed

in t

ime.

No

inte

rnet

.

13A

Publ

ic, f

ees,

dono

rYe

s, sp

ecia

l ac

coun

tN

oN

o5

+10

Insu

ffi c

ient

No

orga

nigr

am o

r jo

b de

scrip

tion

s, no

HR

deve

lopm

ent

plan

No

Lim

ited

info

rmat

ion

avai

labl

e; li

ttle

vis

i-bi

lity.

Act

ion

plan

fo

r go

od g

over

nanc

e

No

Dire

ctor

is a

lso

head

of

tend

er b

oard

14A

Publ

icN

o de

tail e

d pl

anN

o15

+10

Nee

d tr

aini

ng

Five

-yea

r pl

an, n

o de

tails

on

fund

ing

Som

e co

nsul

tati

on

(pro

f. as

soci

atio

ns)

No

Very

lim

ited

bud

get

18A

Publ

ic, f

ees

to

gove

rnm

ent

No

No

Bein

g dr

afte

d13

tec

hnic

al

Insu

ffi c

ient

No

HR

deve

lopm

ent

plan

, no

lega

l sup

port

No

Som

e co

nsul

tati

on.

Web

site

nee

ds

regu

lar

upda

tes

Yes

No

proc

edur

es

esta

blis

hed

for

tech

nica

l com

mit

tees

19C

Publ

ic, f

ees

(no

lega

l bas

is),

dono

rYe

s, sp

ecia

l ac

coun

t

? N

ot

back

ed b

y la

wN

o61

Insu

ffi c

ient

No

HR

deve

lopm

ent

plan

, tra

inin

g co

nduc

ted

ad h

oc

Part

ial

(con

fi den

tialit

y on

ly)

Insu

ffi c

ient

con

sul-

tati

on. W

ebsi

te

unde

r co

nstr

ucti

on**

Thre

e un

its

loca

ted

in

diff

eren

t pl

aces

. Boa

rd

not

appo

inte

d.

22A

Publ

ic, f

ees,

dono

rYe

s, ex

cept

lic

ensi

ng

fees

No

No

11 t

echn

ical

Insu

ffi c

ient

No

spec

ifi c

trai

ning

, no

dev

elop

men

t pl

an.

No

orga

nigr

am o

r jo

b de

scrip

t.

No

Acti

on p

lan,

but

no

spec

ifi c

mea

sure

s to

pr

omot

e tr

ansp

aren

cyN

o

Infl e

xibl

e fu

ndin

g al

loca

tion

. Lac

k of

ba

sic

equi

p men

t (c

opy

mac

hine

s, te

leph

one

exch

ange

)

23A

Publ

ic, f

ees

to

gove

rnm

ent

No

No

Bein

g in

itia

ted

9 te

chni

cal

Insu

ffi c

ient

No

HR

dev

plan

No

lega

l sup

port

, eig

ht

vaca

nt p

osts

No

Prof

ess.

coun

cil

repr

esen

tati

on. W

eb-

site

not

mai

ntai

ned.

Yes

No

proc

edur

es

esta

blis

hed

for

tech

nica

l com

mit

tees

24C

Publ

ic, f

ees,

dono

rYe

sN

oYe

s, f

or a

dmin

. pr

oces

ses

Insu

ffi c

ient

No

HR

dev

plan

, No

job

desc

ript.

for

key

staf

fG

ener

al (C

iv.

Serv

.)Si

te n

ot u

pdat

ed.

Litt

le c

onsu

ltat

ion

Yes

Poor

infr

astr

uctu

re a

nd

mai

nten

ance

26

A: G

ove

rnm

ent

Dep

artm

ent

, B: B

oar

d/C

ou

nci

l/B

ody

corp

ora

te, C

: par

asta

tal ag

ency

.

27

** =

Web

site

in

trodu

ced a

fter

vis

it [

11]

***

Web

site

no lon

ger

fou

nd in

2009



AN

NE

X 4

: Mar

keti

ng a

utho

riza

tion

+=

exi

stin

g, ±

= e

xist

ing

but i

nade

quat

e, −

= n

ot e

xist

ing

Regi

on

Adeq

uate

lega

l ba

sis

Gui

danc

e fo

r ap

plic

ants

SOP

for

asse

ss-

men

t

Advi

sory

co

mm

itte

eEx

tern

al

asse

ssor

sFu

ll tim

e as

ses s

ors

Secu

re

fi lin

g sp

ace

Com

pute

-ri

zed

syst

em

List

of

appr

o-ve

d pr

oduc

ts,

incl

. SPC

Reco

gni t

ion

of

strin

gent

MRA

s’ de

cisi

ons

Gap

s / r

emar

ks

Coun

try

EAST 02

+±I

nade

quat

e± N

ot a

de-

quat

eTe

chni

cal

com

mit

tee

Lim

ited

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suffi

cie

nt

±± D

atab

ase,

SI

A MED

(for

so

me

part

s)

List

wit

hout

SP

C or

pac

k si

zes

No

Don

atio

ns e

xem

pt

03+ M

inis

ter=

lice

n-

sing a

uth

ori

ty

±Che

ck lis

ts

± Adm

in

only

Yes,

but

no ti

me/

capa

city

No

4In

suffi

cie

nt±

− N

one

List

not

upd

a-te

d, n

o SP

CN

oSc

reen

ing

only

don

e Br

oad

exem

ptio

ns

04+

± Not

com

pre-

hens

ive

? R

eport

form

at

exis

ts

Inte

rnal

, no

tech

nica

l co

mm

itte

es

No

10

Insu

ffi c

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±± S

tand

-alo

ne

data

base

List

not

pub

-lis

hed,

SPC

no

t as

sess

edN

oLo

cal p

rod&

pub

l. se

ctor

ex

empt

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spec

ifi c

requ

irem

ents

for

vac

cine

s

06+

− N

one

− N

one

No

No

Insu

ffi c

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±−

Non

eLi

st n

ot

publ

ishe

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oM

A gr

ante

d w

itho

ut d

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eval

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co

mpr

ehen

s. N

o gu

idan

ce

on B

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stab

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one

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op

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1 ye

ar

befo

re

visi

t, no

fu

nds

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ffi c

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±± S

tand

-alo

ne

data

base

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out

date

d,

not

publ

ishe

dU

S-FD

A, W

HO

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, EU

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ptio

ns f.

orph

an p

ro du

cts,

publ

ic se

ctor

impo

rts

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ssm

ents

sto

pped

09± R

equi

rem

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no

t sp

ecifi

ed± N

ot d

etai

led,

ou

tdat

ed−

Non

eN

ot

oper

atio

nal

Tran

siti

o-na

l, in

acti

ve

3In

suffi

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one

List

exi

sts,

but

no w

ebsi

teCP

P re

ques

ted

No

ongo

ing

eval

uati

on(n

o te

ch. c

apac

ity)

10−

(Pro

pose

d, n

o de

tails

)--

-n/a

---

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-n/a

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a--

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---

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lato

ry s

yste

m n

ot y

et

esta

blis

hed

15+

+ Det

aile

d in

fo

on for

mat

/

conte

nt

+ Wri

tten

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Yes

Yes

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ffi c

ient

±± n

etw

orke

d M

IS d

'bas

e Li

st w

itho

ut

SPC

Supe

rfl u

ous

step

of

"pre

-re

gist

rati

on"

of g

ener

ics

and

esse

ntia

l med

s

16± A

ct, b

ut n

o re

gula

tion

s±N

ot u

pdat

ed

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eN

ot

oper

atio

nal

Yes

Insu

ffi c

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±

± Dat

abas

e;

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8 pe

ndin

g ap

plic

atio

ns

Lim

ited

info

, no

t up

date

dN

ot f

orm

alN

o sp

ecifi

c re

quire

men

ts f

or

vacc

ines




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on

Adeq

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lega

l ba

sis

Gui

danc

e fo

r ap

plic

ants

SOP

for

asse

ss-

men

t

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sory

co

mm

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tern

al

asse

ssor

sFu

ll tim

e as

ses s

ors

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re

fi lin

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ace

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pute

-ri

zed

syst

em

List

of

appr

o-ve

d pr

oduc

ts,

incl

. SPC

Reco

gni t

ion

of

strin

gent

MRA

s’ de

cisi

ons

Gap

s / r

emar

ks

Coun

try

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± Few

g'li

nes,

outd

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(1

981)

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eYe

sEx

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yIn

suffi

cie

nt±

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eN

ot p

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hed

(200

9: w

eb)

No

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prov

isio

ns f

. vac

cine

s; n

o gu

idan

ce o

n va

riati

ons

26± N

o de

taile

d le

gal i

nstr

umen

t

+ Tec

hnic

al

info

not

consi

sten

tly

update

d

± Not

for

en

tire

pr

oces

sYe

sN

o6

±± S

IAM

ED

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data

base

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pub

li she

d (2

009:

web

)CP

P re

view

ed,

not

requ

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All o

ral s

olid

dos

e an

ti-

infe

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xem

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bi

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on for

mat

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conte

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ck lis

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exp

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com

mit

tees

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u siv

ely,

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ifi ed

ex

pert

s

Non

e

Insu

ffi c

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+± S

tand

-alo

ne

data

base

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st w

itho

ut

SPC

Yes,

defi n

ed li

st o

f M

RAs

Rem

u ner

atio

n is

sues

, del

ays.

Asse

ssm

ents

tak

e 12

-24

mon

ths

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± Not

com

pre-

hen s

ive

E.g

no

guid

e lin

e fo

r re

new

al

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eYe

sYe

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l par

-ti

cipa

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ffi c

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one

Out

date

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ions

fro

m

othe

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MRA

s re

ques

ted

Proc

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can

take

5 y

ears

Back

log

of a

ppro

x. 1

000

appl

icat

ions

MID

DLE

05± A

ct, b

ut n

o re

gula

tion

s−N

one

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eN

oN

oIn

suffi

cie

nt±

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eN

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stem

not

yet

ope

ra ti

o nal

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ona t

ions

exe

mpt

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ida t

ed

SOPs

7 sp

ecia

lized

1

natio

nal

Yes

4

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fi cie

nt±

+SIA

MED

CPP

requ

este

dN

o pr

oced

ure

for

vete

rinar

y pr

oduc

ts

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eN

ot f

or M

A sp

ecifi

cally

No

3

Insu

ffi c

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one

No

regu

lati

ons

for

vacc

i nes

, re

agen

ts, v

et m

eds

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in

only

Yes

Yes

2

Insu

ffi c

ient

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IAM

ED

No

proc

edur

es f

or t

echn

ical

ev

alua

tion

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+ Bri

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escr

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on

of

requi-

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ponen

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det

aile

d,

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noffi

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ffi c

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IRAP

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not

opti

mal

Yes;

SPC

not

in

clud

ed in

re

gist

rati

on

cert

ifi ca

te

CPP

requ

este

dM

ainl

y ad

min

istr

ativ

e re

view

. Fe

w re

quire

men

ts f

or g

ener

ics



Regi

on

Adeq

uate

lega

l ba

sis

Gui

danc

e fo

r ap

plic

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for

asse

ss-

men

t

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sory

co

mm

itte

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tern

al

asse

ssor

sFu

ll tim

e as

ses s

ors

Secu

re

fi lin

g sp

ace

Com

pute

-ri

zed

syst

em

List

of

appr

o-ve

d pr

oduc

ts,

incl

. SPC

Reco

gni t

ion

of

strin

gent

MRA

s’ de

cisi

ons

Gap

s / r

emar

ks

Coun

try

WES

T

01+B

rief

outl

ine

± Brie

f, no

te

ch ni

cal

guid

ance

+ Ma nual &

guid

eYe

sYe

s4

Suf

fi cie

nt+

+SIA

MED

CP

P re

ques

ted

Vacc

ines

not

regu

late

d by

MRA

13± I

nco

mple

te a

nd

outd

ate

d r

egula

-

tions

± Not

su

ffi c

ient

ly

deta

iled,

ou

tdat

ed

± Adm

in

only

Yes

(no

spec

ifi c

expe

rtis

e)

Yes,

and

QC

lab

staf

f

3In

suffi

cie

nt±

+SIA

MED

SPC

not

incl

uded

in

regi

stra

tion

ce

rtifi

cate

No

Mai

nly

adm

inis

trat

ive

revi

ew. S

ome

dona

tion

s an

d in

vest

igat

iona

l pro

duct

s ex

empt

14± D

atin

g fr

om

1994

±Som

e± I

nfor

mal

in

tern

al

doc

Yes;

no

spec

ializ

ed

com

mit

tees

Yes

(few

)4

Insu

ffi c

ient

±− M

anua

l on

ly; m

ajor

pr

oble

m

List

not

pub

-lis

hed,

SPC

no

t as

sess

ed

Rene

wal

of

MA

not

follo

wed

up

by

NM

RA o

r ap

plic

ants

18+

± Reg

ulat

ion

and

Circ

ular

± Adm

in

only

Yes

Yes

Insu

ffi c

ient

++ S

IAM

ED

(back

log)

2009

: Lis

t on

web

site

(no

SPC)

No

No

proc

edur

es f

or t

echn

ical

ev

alua

tion

19± I

ncom

ple t

e re

gula

tion

s± N

ot c

ompr

e-he

nsiv

e±S

ome

Info

rmal

Yes

10In

suffi

cie

nt±

−Non

eDe

c 09

: list

of

Oct 0

8 on

web

-sit

e, no

SPC

No

Lack

of

asse

ssor

s a

maj

or

prob

lem

; pro

ce du

res

need

im

prov

emen

t

22+

± Not

su

ffi c

ient

ly

deta

iled,

ou

tdat

ed

± Adm

in

only

Yes

(few

m

eeti

ngs,

dela

ys)

No

1In

suffi

cie

nt±

± Exc

el, n

ot

netw

orke

d

Regi

stra

tion

ce

rtif

. has

lim

i ted

in

form

atio

n

No

Mai

nly

adm

inis

trat

ive

revi

ew.

Lack

of

spec

ifi c

skill

s an

d in

form

atio

n

23+

± Circ

ular

de

scrib

ing

the

proc

ess

± Adm

in

only

Nat

iona

l co

mm

itte

eYe

s2

Insu

ffi c

ient

±

+SIA

MED

N

oTe

chni

cal p

roce

dure

s ne

ed

impr

ovem

ent

24+

? G

uid

ance

has

bee

n

publish

ed

± Adm

in

only

No

Vario

us

in te

r nal

co

m-

mit

tees

Insu

ffi c

ient

±± D

atab

ase

netw

orke

d w

ithi

n de

pt.

List

gaz

ette

d,

web

not

up

date

d, n

o SP

C

Yes,

coun

try

of

orig

inD

onat

ions

, orp

han

med

icin

es

exem

pt




AN

NE

X 5

: Lic

ensi

ng o

f ac

tivi

ties

= N

MRA

; a

noth

er b

ody,

= tw

o ot

her b

odie

s, =

NM

RA a

nd a

noth

er b

ody,

= N

MRA

and

two

othe

r bod

ies,

= n

ot a

ssig

ned

to a

spe

cifi c

bod

y

Regi

onAu

tho r

ity

Des

crip

tion

, gap

sCo

untr

y

EAST 02

Ap

prov

al t

o m

anuf

actu

re is

gra

nted

on

a pr

oduc

t-by

-pro

duct

bas

is; m

anuf

actu

rers

are

sup

port

ed t

o m

eet

min

imum

GM

P st

anda

rds.

03

Cont

rol b

y tw

o di

ffer

ent

com

mit

tees

(one

for

man

ufac

ture

rs /

dist

ribut

ors,

anot

her

for

reta

il), s

ome

rene

wal

s w

itho

ut in

spec

tion

s. S

ome

faci

litie

s op

erat

e un

der

locu

m

phar

mac

ists

for

mon

ths.

List

of

licen

sed

busi

ness

es n

ot r

eadi

ly a

vaila

ble

04

NM

RA c

erti

fi es

com

pete

nce

(pub

lic s

ecto

r ex

empt

), li

cens

e by

Min

istry

of T

rade

. G

MP

not

in li

ne w

ith

WH

O s

tand

ards

. Ret

ail:

regi

onal

con

trol

but

repo

rtin

g sy

stem

not

fi na

lized

. Poo

r coo

pera

tion

with

oth

er n

atio

nal e

nfor

cem

ent a

genc

ies (

cust

oms,

polic

e).

06

Lice

nce

requ

ired

by la

w, b

ut re

gula

tion

s ex

ist

for

phar

mac

ies/

depo

ts o

nly

07N

atio

nal a

nd R

egio

nal M

oH (n

o of

fi cia

l del

egat

ion

to t

he la

tter

, no

regu

lar

repo

rtin

g sy

stem

). Li

cenc

es h

ave

no v

alid

ity

date

. Pub

lic h

ospi

tal p

harm

acie

s ex

empt

. 09

Min

istr

y of

Pub

lic H

ealt

h on

Insp

ecto

rate

's ad

vice

; few

req

uire

men

ts f

or m

anuf

actu

rers

and

dis

trib

utor

s10

(Ret

aile

rs in

spec

ted

by P

ublic

Hea

lth

insp

ecto

r)

15Sc

atte

red

resp

onsi

bilit

ies:

Dep

2,3,

6 (lo

cal m

anuf

actu

rers

), D

ep6

(for

eign

man

ufac

ture

rs)

Dep

3+re

gion

al a

utho

ritie

s (r

etai

l)16

Regu

lati

ons

on c

ontr

ols

of d

istr

ibut

ion

chan

nels

not

ena

cted

20N

MRA

& Q

C La

b (f

or m

anuf

actu

rers

& re

tail)

- c

onfl i

ctin

g re

spon

sibi

litie

s; u

ncle

ar e

xem

ptio

ns (e

.g. h

ospi

tal p

harm

acie

s). M

oH In

spec

tora

te (f

or d

istr

ibut

ors)

. 26

N

MRA

(man

ufac

ture

rs &

dis

trib

utor

s). M

oH li

cens

es p

ri va t

e ph

arm

acie

s, no

rul

es f

or p

ublic

hos

pita

l pha

rmac

ies

SOU

TH 11N

MRA

(in

conn

ecti

on w

ith

MA)

Prof

essi

onal

cou

ncil

(for

est

ablis

hmen

ts)

21M

oH (l

icen

ces

issu

ed b

y M

in. T

rade

) Pub

lic h

ealt

h fa

cilit

ies

and

disp

ensi

ng d

octo

rs n

ot in

spec

ted

MID

DLE

05

Cont

rol b

y N

atio

nal H

ealt

h In

spec

tora

te +

Min

istr

y of

Com

mer

ce, b

ut n

o en

ablin

g re

gula

tion

s on

goo

d pr

acti

ces

for

man

ufac

turin

g, s

ale

and

disp

ensi

ng08

N

MRA

(pre

para

tion

), M

inis

try

Pub

Hea

lth

(ret

aile

rs).

Prof

essi

onal

cou

ncil

(man

ufac

ture

rs, d

istr

ibut

ors,

impo

rter

s)

12

Cont

rol b

y th

ree

diff

eren

t de

part

men

ts, d

epen

ding

on

prod

uct

type

Som

e ph

arm

acie

s ha

ve m

unic

ipal

app

rova

l onl

y17

N

MRA

(for

man

ufac

ture

rs, d

istr

ibut

ors,

reta

ilers

). Pr

ofes

sion

al c

ounc

il le

vies

fee

for

reta

ilers

, no

cont

rol o

f m

edic

ine

shop

s

25M

oH, o

n ad

vice

of

NM

RA a

nd H

ealt

h in

spec

tora

te.

Requ

irem

ents

not

defi

ned

WES

T01

Cont

rol b

y tw

o di

ffer

ent

depa

rtm

ents

, dep

endi

ng o

n pr

oduc

t ty

pe. N

o G

MP

insp

ecti

ons

13Ap

prov

al b

y M

inis

ter

of H

ealt

h on

adv

ice

of p

rofe

ssio

nal c

ounc

il an

d te

chni

cal c

omm

itte

e. In

spec

tion

onl

y af

ter

licen

ce is

gra

nted

. GDP

not

req

uire

d fo

r di

stri

buto

rs. S

ome

unlic

ense

d fa

cilit

ies

(e.g

. fai

th-b

ased

)

14

Cont

rol b

y tw

o di

ffer

ent

depa

rtm

ents

(one

for

man

ufac

ture

rs, a

lso

task

ed t

o pr

omot

e lo

cal i

ndus

try,

ano

ther

for

dis

trib

utor

s an

d re

taile

rs).

Inad

equa

te in

form

atio

n m

anag

emen

t.18

N

o op

erat

ing

proc

edur

es

19

NM

RA +

insp

ecto

rs f

rom

oth

er d

epar

tmen

ts (f

or m

anuf

actu

rers

)

Prof

essi

onal

Cou

ncil

(for

dis

trib

utor

s, re

taile

rs)

22M

oH o

n ad

vice

of N

MRA

, Ins

pect

orat

e, P

rofe

ssio

nal C

ounc

ils. N

o sp

ecifi

c re

gula

tions

for v

ario

us ty

pes o

f est

ablis

hmen

ts. G

SP re

quire

d bu

t not

pub

lishe

d. S

ome

unlic

ense

d di

stri

buto

rs.

23N

o SO

Ps in

pla

ce f

or li

cens

ing

24

Phar

mac

euti

cal a

ctiv

itie

s co

ntro

lled

by p

rofe

ssio

nal c

ounc

il (n

o lic

ensi

ng f

or m

anuf

actu

rers

of

inve

stig

atio

nal p

rodu

cts)



AN

NE

X 6

: Im

port

con

trol

Regi

onD

escr

ipti

on, g

aps

Coun

try

EAST 02

Cont

rol o

f AP

Is a

nd F

PPs

by re

view

ing

pro-

form

a in

voic

es

03Im

port

: Not

enf

orce

d, n

o in

spec

tion

sys

tem

; pro

duct

s fo

r sp

ecifi

c pa

tien

ts e

xem

pt. E

xpor

t: n

o le

gal r

equi

rem

ents

04Sp

ecifi

c pr

ovis

ions

on

impo

rt /e

xpor

t ex

ist

for

narc

otic

s on

ly. I

mpo

rt b

ased

on

nati

onal

med

icin

es li

st o

r w

ritte

n re

ques

t by

a d

octo

r

06Li

cens

ed e

stab

lishm

ents

can

impo

rt p

harm

aceu

tica

ls w

itho

ut a

ny r

equi

rem

ents

07M

A no

t re

quire

d fo

r pu

blic

sec

tor

impo

rts;

no

actu

al in

spec

tion

09N

MRA

, bas

ed o

n M

A (n

o lis

t of

lice

nsed

dis

tri b

utor

s). P

rivat

e co

mpa

ny c

ontr

ols

impo

rt a

cts

and

prep

ares

doc

umen

tati

on.

10Im

port

con

trol

not

yet

impl

emen

ted

15M

A ne

eded

, but

no

list

of e

xem

p t p

rodu

cts

16Le

gal b

asis

but

no

regu

lati

ons

enac

ted

20N

o w

ritte

n gu

idel

ines

for

impo

rt /

expo

rt li

cenc

es; l

ist

of li

cens

ed im

port

ers

and

expo

rter

s no

t re

adily

ava

ilabl

e

26An

nual

lice

nce

& v

erifi

cati

on o

f ea

ch im

port

. Les

s co

ntro

l for

unr

egis

tere

d pr

oduc

ts

SOU

TH 11Im

port

ed p

rodu

cts

need

MA;

NM

RA re

view

s Co

As

21Im

port

ed/e

xpor

ted

prod

ucts

nee

d M

A. P

rodu

cts

impo

rted

by

Cent

ral M

edic

al S

tore

s an

d

dona

ted

drug

s ar

e ex

empt

ed f

rom

regi

stra

tion




Regi

onD

escr

ipti

on, g

aps

Coun

try

MID

DLE

05N

o sp

ecifi

c re

quire

men

ts t

o co

ntro

l im

port

of

APIs

, no

cert

ifi ca

tion

of

expo

rts

08 12Ap

prox

. 90%

of

prod

ucts

impo

rted

.

1710

0% o

f pr

oduc

ts im

port

ed. S

ince

200

7 im

port

atio

n on

ly t

hrou

gh li

cens

ed w

hole

sale

rs, b

ut n

ot c

ontr

olle

d in

pra

ctic

e

25Im

port

ed p

rodu

cts

need

MA,

but

som

e ex

cept

ions

. NM

RA a

utho

rizes

impo

rts

for

spec

ifi c

trea

tmen

t ne

eds

wit

hout

offi

cia

l del

egat

ion

and

wit

hout

defi

ned

pro

ce du

re. L

ack

of r

egul

atio

n fo

r do

nati

ons.

Exp

ort

not

regu

late

d

WES

T

0198

% o

f m

edic

ines

impo

rted

. Reg

ulat

ions

to

be a

dopt

ed

13W

ide

rang

e of

aut

hori

zed

impo

rter

s; n

o sy

stem

to

keep

tra

ck o

f pr

oduc

t st

atus

(MA)

, reg

ulat

ions

not

ade

quat

e to

con

trol

don

atio

ns

14Ba

sed

on M

A, b

ut n

o co

mpu

teri

zed

lists

18La

ck o

f co

ntro

l for

inve

stig

atio

nal p

rodu

cts

19Im

port

ers

licen

sed

by p

rofe

ssio

nal c

ounc

il; N

MRA

has

no

lega

l bas

is f

or in

spec

tion

22N

eed

appr

oval

by

MoH

on

advi

ce o

f N

MRA

. No

syst

em t

o ve

rify

lot

num

bers

, aut

hori

zed

impo

rter

s, r

egis

tere

d pr

oduc

ts. N

o ac

tive

col

labo

rati

on w

ith

cust

oms

23M

A ne

eded

, but

exe

mpt

ions

unc

lear

24O

nly

licen

sed

esta

blis

hmen

ts c

an im

port

. NRA

scr

eens

doc

umen

ts, s

ome

insp

ecti

ons/

tes

ting



AN

NE

X 7

: Ins

pect

ions

= N

MRA

; a

noth

er b

ody,

= N

MRA

and

ano

ther

bod

y+=

exi

stin

g; ±

= e

xist

ing

but i

nade

quat

e, −

= n

ot e

xist

ing

Regi

onAu

thor

ity

/ ies

in c

harg

eLe

gal b

asis

GM

P re

quire

d

Publ

ishe

d G

MP

guid

elin

es

Publ

ishe

d G

DP

guid

elin

es

SOP

for

insp

ecti

onQ

MS

Insp

ec to

rsIn

spec

-to

rs

Lo gi

s-ti

csM

ain

gaps

/ re

mar

ksCo

untr

y

EAST 02

+

regio

nal offi

cer

s+

Yes

± Not

to

WH

O

stan

dard

sN

one

±Che

cklis

t−

10

+reg

iona

l+

±Po

or c

oord

ina t

ion,

inex

perie

nced

in

spec

tors

03+

Bein

g ph

ased

in−N

one

±Che

cklis

t, ou

tdat

ed−

2 +4

as

sist

ants

±±

Phar

mac

ists

fro

m d

istr

ibut

ion

chan

nels

do

insp

ecti

ons:

con

fl ict

of

inte

rest

04

+ R

egio

nal

bra

nch

es

± No

spec

if. p

ro -

visio

ns to

con

-tr

ol a

ctiv

ities

No

± Not

to

WH

O

stan

dard

sN

one

±Che

cklis

t−

10 p

h'ci

sts

(cen

tral

le

vel)

±±

Lack

of

staf

f, tr

aini

ng, e

xper

ienc

e an

d re

sour

ces

06

+

Yes

(no

re-

gula

tion

s)−N

one

Non

e−N

one

−2

±±

Lack

of

staf

f an

d re

sour

ces,

not

func

tion

al

07+

Reg

ional M

oH

inoffi

cia

l)+

Yes

−Non

eN

one

±Che

cklis

t−

3±

±La

ck o

f tr

ansp

ort

a m

ajor

pro

blem

09

Public

hea

lth

in sp

ec to

rate

+N

o−N

one

Non

e±C

heck

list

−6

±±

Seve

re la

ck o

f qu

alifi

ed s

taff

Del

ays

in re

leas

e of

fun

ds

10

Hea

lth insp

ecto

r± P

harm

a cie

s on

lyn/

an/

an/

a1

±±

Insp

ecti

ons

of p

harm

acie

s w

ere

the

only

regu

lato

ry f

unct

ion

15

+ R

egio

nal +

QC

L

staff

+Ye

s± W

orke

d ou

t by

loca

l co

mm

itte

e16

±±

Larg

e di

ffer

ence

s in

str

inge

ncy

betw

een

regi

ons

16

+R

egio

nal

±No

regu

lati

ons

Not

for

M

A± N

ot t

o W

HO

st

anda

rds

−Non

e−

6 +1

7 pa

rt

tim

e±

±St

aff,

fund

s an

d G

MP

trai

ning

ne

eded

. No

rout

ine

insp

ecti

ons

20+

MoH

+Q

C s

taff

+N

o+ W

HO

tex

t, na

t. dr

aft

unfi n

ishe

dN

one

−Non

e−

4±

±Fe

w in

spec

tion

s. N

o pl

an f

or f

ollo

w-

up

26

+ R

egio

nal st

aff

+N

o

− Unp

ub-

lishe

d dr

aft

mod

eled

on

PIC/

S

Non

e±C

heck

list

−33

+65

re

gion

al+

+H

ospi

tal p

harm

acie

s no

t re

gula

rly

insp

ecte

d

SOU

TH 11+

Pro

fess

ional

counci

l+

Yes

+Ye

s±O

utda

ted

−To

be

set

up

NM

RA: 1

0

Coun

cil:

34

part

-tim

e

++

NM

RA n

ot in

cha

rge;

Pro

fess

. cou

ncil

mak

es fi

nal d

ecis

ion

base

d on

GM

P in

spec

tion

repo

rts,

and

insp

ects

di

strib

utio

n ch

ain

21

− (Fu

ncti

on n

ot

men

tion

ed in

Ac

t)Ye

s−N

one

Non

e±C

heck

list

−N

o±

±La

ck o

f re

sour

ces,

no re

spon

sibl

e pe

rson

. Pub

l. se

ctor

out

lets

& d

is pe

ns.

doct

ors

not

insp

ecte

d




Regi

onAu

thor

ity

/ ies

in c

harg

eLe

gal b

asis

GM

P re

quire

d

Publ

ishe

d G

MP

guid

elin

es

Publ

ishe

d G

DP

guid

elin

es

SOP

for

insp

ecti

onQ

MS

Insp

ec to

rsIn

spec

-to

rs

Lo gi

s-ti

csM

ain

gaps

/ re

mar

ksCo

untr

y

MID

DLE

05

Pub H

ealt

h

insp

ecto

rate

+reg

ional st

aff

+N

o (p

ropo

sed

for

MA)

±Not

to

WH

O

stan

dard

sN

one

−Non

e−

69

+±

Insp

ecto

rate

not

wel

l equ

ippe

d.

To s

erve

as

enfo

rcem

ent

arm

for

pr

opos

ed N

MRA

08

MoH

in sp

ecto

rate

+N

o−N

one

Non

e−N

one

−±

±La

ck o

f st

aff

and

reso

urce

s, po

or

coor

dina

tion

wit

h N

MRA

12

Sev

eral N

RA

dep

art

men

ts

+re

gio

nal

± Not

spe

cifi c

to

typ

es o

f in

spec

tion

No

−Non

eN

one

−Non

e−

24±

±La

ck o

f st

aff

and

reso

urce

s; n

o re

port

s

17± N

o in

spec

tors

’ st

atus

N

o−N

one

Non

e±C

heck

list

−+

±La

ck o

f re

sour

ces

25D

ivis

ion o

f

Public

Hea

lth

Insp

ecto

rate

+N

o−N

one

Non

e−N

one

−±

±La

ck o

f st

aff

and

reso

urce

s

WES

T

01

Public

Hea

lth

Insp

ecto

rate

+N

o±N

ot t

o W

HO

st

anda

rds

Not

to

WH

O

stan

dard

s−N

one

−2

±±

Lack

of

staf

f an

d re

sour

ces,

poor

co

ordi

nati

on w

ith

NM

RA

13In

spec

tors

nam

ed

by

Min

Pub

Hea

lth

± Ins

pect

ors'

pow

ers

not

wel

l de

fi ned

Yes

−Non

e−N

one

±Che

cklis

t−

4 (in

cl.

one

from

N

MRA

)±

±Re

port

s ad

dres

sed

to M

in P

ub H

ealt

h.

Annu

al p

lan

not

fulfi

lled

due

to la

ck

of in

spec

tors

and

reso

urce

s

14+

MoH

± Res

pons

i bili

ties

no

t cl

ear

No

+WH

O t

ext

WH

O t

ext

−Non

e−

27;

2 fr

om

Min

istr

y of

he

alth

±±

Lack

of

staf

f. Af

fi lia

tion

of

insp

ecto

rs

uncl

ear

18

Hea

lth I

n-

spec

tora

te+

?

Not

for

M

A

−Non

eN

one

+Yes

10±

±An

nual

pla

ns n

ot m

et d

ue t

o la

ck o

f st

aff

and

reso

urce

s

19+

Pro

fess

ional

Counci

l+

No

+WH

O t

ext

? (C

ontr

ol

by C

ounc

il)

± Not

co

mpr

e-he

nsiv

e−

6 +f

rom

ot

her

dep

±±

Lack

of

staf

f an

d re

sour

ces.

Coun

cil

lack

s re

sour

ces

to c

arry

out

its

man

date

22+

Hea

lth

Insp

ecto

rate

± Som

e re

gu-

la ti

ons

not

publ

ishe

d

Yes (

regu

-la

tion

not

publ

ished

)−N

one

Non

e−N

one

−?

Non

e fr

om

NM

RA±

±N

o le

gally

em

pow

e red

NM

RA

insp

ecto

rs, i

nspe

ctor

ate

staf

f no

t ph

arm

acis

ts

23+

Yes

+N

one

+ Yes

, not

validate

d−

±±

Lack

of

staf

f; G

MP

trai

ning

nee

ded

24+

Pro

fess

ional

Counci

l+

Yes

(no

regu

la-

tions

) −N

one

Non

e±C

heck

list

−53

8±

±O

verla

p of

act

ivit

ies

(NM

RA/C

ounc

il)

– gr

ey a

reas



AN

NE

X 8

: Qua

lity

cont

rol

= N

MRA

; =

ano

ther

bod

y, =

two

othe

r bod

ies,

= n

o Q

C la

b;

+= e

xist

ing,

± =

exi

stin

g bu

t ina

dequ

ate,

−=

not

exi

stin

g;

----

---=

no

QC

lab

(not

revi

ewed

)

Regi

onDe

scri

ptio

n of

reg

ulat

ory

QC

labo

rato

ryQ

ualit

y m

anag

e men

t sy

stem

St

aff

(tec

h+ad

min

)

Equi

pmen

t

& m

aint

enan

ceCo

untr

y

EAST 02

NM

RA d

epar

tmen

t. Te

sts

pre-

mar

keti

ng s

ampl

es

+Can b

e st

rength

ened

+(13 t

ech.)

+

03H

ouse

d at

Cen

tral

Med

Sto

res;

mai

nly

test

s pu

blic

. sec

tor

impo

rts

− Not

fun

ctio

nal (

som

e SO

Ps)

±±I

nade

quat

e

04N

MRA

dep

artm

ent.

Test

s pr

e-m

arke

ting

sam

ples

. − N

o w

ritte

n sy

s tem

, no

SOPs

±(16

tec

h, la

ck o

f ski

lls)

± Lac

king

som

e m

ajor

eq

uipm

ent

06N

one.

Ext

erna

l lab

s us

ed--

----

---

----

---

----

-

07N

atio

nal Q

C la

b. N

o lin

k w

ith

NM

RA. T

ests

pub

lic s

ecto

r im

port

s± I

n fi r

st s

tage

of

impl

emen

tati

on+(

20 +

6)+ L

ack

of sp

ace/

mai

nten

ance

09Ex

tern

al (c

ostl

y, d

elay

s); N

atio

nal H

ealt

h In

stit

ute

(not

yet

set

up)

----

---

----

---

----

---

10(N

one,

NM

RA n

ot in

pla

ce)

----

---

----

---

----

---

15Af

fi lia

ted

wit

hout

lega

l bas

is. P

re-m

arke

t Q

C fo

r ea

ch b

atch

, not

effi

cie

nt. L

ack

of

fund

s+ A

spir

ing t

o I

SO

17025

cert

ifi c

at.

+(33+

3)

+Lack

of

space

16N

ot o

pera

tion

al s

ince

199

9; n

ew la

bora

tory

pro

pose

d--

----

---

----

---

----

-

20Au

tono

mou

s la

b, s

taff

sec

onde

d by

MoH

− Rep

orte

dly

bein

g de

velo

ped

? (1

1 te

ch)

+

26Te

sts

fi rst

3 b

atch

es o

f al

l loc

al p

rodu

ctio

n+ Q

Manual and s

ever

al SO

Ps

+(12 t

ech)

+Lack

of

space

SOU

TH 11M

oH la

b/ac

adem

ia/p

rivat

e; C

ontr

acti

ng-o

ut d

isco

ntin

ued

----

---

----

---

----

---

21Ce

ntra

l Med

ical

Sto

res

lab;

no

lega

l bas

is?

(10

tech

)±B

asic

MID

DLE




Regi

onDe

scri

ptio

n of

reg

ulat

ory

QC

labo

rato

ryQ

ualit

y m

anag

e men

t sy

stem

St

aff

(tec

h+ad

min

)

Equi

pmen

t

& m

aint

enan

ceCo

untr

y

05N

one;

sol

e m

anuf

actu

rer's

lab

used

----

---

----

---

----

---

08N

at.L

ab; t

ests

pre

-MA

sam

ples

+Re

s Cen

tre

(poo

r coo

rdin

a tio

n) +

12N

one,

4 a

ppro

ved

labs

con

trac

t ed

by M

in P

ub H

ealt

h--

----

---

----

---

----

-

17N

one,

out

side

labs

use

d; Q

C la

b to

be

set

up b

y 20

10--

----

---

----

---

----

-

25N

one,

ext

erna

l lab

s us

ed. S

tudy

to

set

up Q

C la

b un

der

way

----

---

----

---

----

---

WES

T

01N

at. P

ublic

Hea

lth

lab.

Tes

ts p

re-m

arke

ting

sam

ples

±L

ack

of s

kills

±Not

opt

imal

ly u

sed

13 N

atio

nal l

ab; w

ide

rang

e of

tas

ks−S

ome

SOPs

+(

Exce

pt f

or b

iolo

gica

ls)

+ Lac

k of

spa

ce; b

eing

re

hous

ed

14N

atio

nal l

ab, t

ests

sam

p les

for

MA.

Man

y ot

her

func

tion

s. ± B

eing

set

up,

par

tly

func

tion

al+

±Mos

tly

old

18N

atio

nal Q

C La

b, t

ests

pre

-mar

keti

ng s

ampl

es

−Will

be

set

up+(

12 t

ech)

+

19N

MRA

Lab

ser

vice

±No

resp

on si

ble

pers

on+

+Lac

k of

spa

ce

22N

atio

nal l

ab+W

HO

/ISO

170

25 s

tandar

ds

+(Exc

ept

for

bio

logic

als

)+ L

ack

of

envi

ron m

enta

l

contr

ol

23N

atio

nal l

ab, r

ecei

ves

doss

iers

and

tes

ts s

ampl

es+ M

anual/

SO

Ps

base

d o

n

OEC

D+(

16 t

ech)

+

24Ye

s (n

ot re

view

ed d

urin

g vi

sit)

Test

s pr

e-m

arke

ting

sam

ples

Not

revi

ewed

Not

revi

ewed

Not

revi

ewed



AN

NE

X 9

: Mar

ket

surv

eilla

nce

= N

MRA

; =

ano

ther

bod

y, =

not

ass

igne

d to

any

offi

cial

bod

y;

+

= e

xist

ing,

± =

exi

stin

g bu

t ina

dequ

ate,

−=

not

exi

stin

g

Regi

onPr

oduc

t qu

alit

y Pr

oduc

t qu

alit

y m

onit

orin

g m

onit

orin

g Q

C te

stin

g of

Q

C te

stin

g of

sa

mpl

essa

mpl

esAn

ti-c

ount

erfe

itin

g An

ti-c

ount

erfe

itin

g pr

ogra

mm

epr

ogra

mm

eN

MRA

pro

ce du

re f

or

NM

RA p

roce

dure

for

ef

fect

ive

reca

llef

fect

ive

reca

ll

Phar

mac

ovig

ilanc

e sy

stem

Ph

arm

acov

igila

nce

syst

em

*=m

embe

r of

WH

O P

rogr

amm

e f.

*=m

embe

r of

WH

O P

rogr

amm

e f.

Int'l

Dru

g M

oni t

orin

g at

tim

e of

vis

it

Int'l

Dru

g M

oni t

orin

g at

tim

e of

vis

it

(htt

p://w

ww

.who

-um

c.or

ght

tp://

ww

w.w

ho-u

mc.

org/

) )

Cont

rol o

f pr

omot

ion

Cont

rol o

f pr

omot

ion

Meds in formation Meds in formation

Coun

try

EAST 0202

+ Sam

ple

s co

llec

ted a

nd

test

ed

± Sur

veill

ance

for

cou

nter

-fe

its

(to

be s

tren

gthe

ned)

−Non

e±*

Man

ual r

ecor

ding

, res

ults

sen

t to

W

HO

-UM

C. 8

2 re

port

s re

ceiv

ed in

ye

ar b

efor

e vi

sit.

± Not

alw

ays

effe

ctiv

e; S

PC n

ot

avai

labl

e. M

ed. r

eps

subj

ect

to

cont

rol

++

0303− N

o PM

S sy

stem

(in

prep

arat

ion)

Few

Few

± Sur

veill

ance

by

insp

ecto

rs,

no s

peci

fi c p

rogr

amm

e− L

egal

pro

visi

on n

ot

impl

emen

ted

−No

syst

em−N

ot im

plem

ente

d−−

0404−N

o PM

S sy

stem

In c

ase

of

In c

ase

of

com

plai

nts

com

plai

nts

−Non

e± R

epor

ts re

ceiv

ed, l

ack

of e

x per

ts f

or

asse

ssm

ent.

± Gui

delin

es n

ot fi

naliz

ed; n

ot b

ased

on

app

rove

d pr

oduc

t in

fo++

0606−N

o PM

S sy

stem

In c

ase

of

In c

ase

of

com

plai

nts

com

plai

nts

−Non

e−N

one

−Not

est

ablis

hed

−No

regu

lati

ons,

not

oper

atio

nal

−−

0707− N

ot im

plem

ente

d, la

ck o

f in

spec

tors

and

tra

nspo

rtN

one

Non

e co

nduc

ted

co

nduc

ted

−N

one

±* M

oH C

entr

e. P

ublic

sect

or, s

e lec

ted

dist

ricts

. Res

ults

sent

to W

HO

-UM

C.

No

link

with

NM

RA

− Som

e le

gal r

equi

rem

ents

, but

no

cont

rol i

n pr

acti

ce

0909−N

o PM

S sy

stem

"If

need

ed"

"If

need

ed"

−Non

e−N

one

−No

syst

em−N

one

−−

1010−N

o PM

S sy

stem

− Non

e. U

nreg

u lat

ed p

rices

fu

el t

he il

licit

mar

ket

−No

NM

RA−N

o sy

stem

−Non

e−−

1515+ S

am

ple

s su

bm

itte

d

by

public

store

s, U

N

agen

cies

, N

GO

s

−Non

e±N

ot c

ompr

e hen

sive

±*

New

ly in

trod

uced

; thr

ee re

port

s tr

ansm

itte

d to

WH

O-U

MC,

tra

inin

g un

der

way

− Leg

al b

asis

exi

sts,

res p

on si

bilit

y ne

wly

as

sign

ed w

ithi

n N

MRA

1616−N

ot o

pera

tion

al−N

one

+ SO

P; f

ol lo

w-u

p du

ring

insp

ecti

ons

− Vag

ue le

gal b

asis

: "m

onit

orin

g sa

fety

". N

o ac

tivi

ty−L

egal

bas

is b

ut n

ot im

plem

ente

d−−

2020± A

d ho

c ba

sed

on f

eed-

back

fro

m t

he m

arke

tIn

cas

e of

In

cas

e of

co

mpl

aint

sco

mpl

aint

s−N

one

−Non

e− U

nit

esta

blis

hed,

no

acti

vity

(la

unch

ed Ju

ne 2

009)

± Gui

delin

es b

ut n

o sy

stem

atic

m

onit

orin

g

2626+ S

am

ple

s purc

hase

d

regula

rly

from

the

mark

et

and

min

ilabs

an

d m

inila

bs

(reg

iona

l)(r

egio

nal)

± Mar

ket

surv

eilla

nce

by

insp

ecto

rs+S

OP

±* V

ague

lega

l bas

is. R

epor

ting

of

adve

rse

even

ts s

ince

200

8.Re

sult

s se

nt t

o W

HO

-UM

C.

± Am

bigu

ous

regu

lati

ons,

unva

lidat

ed

draf

t gu

idel

ine

++

SOU

TH 1111± F

or p

ublic

sec

tor

tend

ers;

no

nat

iona

l sys

tem

± Ins

pect

ions

(out

lets

, por

ts

of e

ntry

, pos

t offi

ces

)+ C

ompl

aint

s-ba

sed

only

+* R

epor

ting

to

WH

O-U

MC,

and

ARV

-sp

ecifi

c ce

ntre

(bei

ng s

et u

p at

tim

e of

vis

it)

+ Mon

itor

ed b

y Ad

vert

isin

g St

anda

rds

Auth

orit

y. S

PC n

ot a

vaila

ble

to c

heck

cl

aim

s++

2121−N

o PM

S sy

stem

−Non

e−N

one

− No

lega

l bas

is. N

o ac

tivi

ty, d

raft

gu

idel

ines

− Not

men

tion

ed in

Act

, not

con

trol

led

in p

ract

ice




Regi

onPr

oduc

t qu

alit

y Pr

oduc

t qu

alit

y m

onit

orin

g m

onit

orin

g Q

C te

stin

g of

Q

C te

stin

g of

sa

mpl

essa

mpl

esAn

ti-c

ount

erfe

itin

g An

ti-c

ount

erfe

itin

g pr

ogra

mm

epr

ogra

mm

eN

MRA

pro

ce du

re f

or

NM

RA p

roce

dure

for

ef

fect

ive

reca

llef

fect

ive

reca

ll

Phar

mac

ovig

ilanc

e sy

stem

Ph

arm

acov

igila

nce

syst

em

*=m

embe

r of

WH

O P

rogr

amm

e f.

*=m

embe

r of

WH

O P

rogr

amm

e f.

Int'l

Dru

g M

oni t

orin

g at

tim

e of

vis

it

Int'l

Dru

g M

oni t

orin

g at

tim

e of

vis

it

(htt

p://w

ww

.who

-um

c.or

ght

tp://

ww

w.w

ho-u

mc.

org/

) )

Cont

rol o

f pr

omot

ion

Cont

rol o

f pr

omot

ion

Meds in formation Meds in formation

Coun

try

MID

DLE

0505± I

nspe

ctor

ate

will

in

vest

igat

e co

mpl

aint

sSu

spec

t Su

spec

t sa

mpl

essa

mpl

es−N

one

−Non

e−N

one

−Non

e−−

0808− L

ack

of in

spec

tors

to

cove

r th

e te

rrit

ory

No

(cos

ts)

No

(cos

ts)

± Mul

ti-s

ecto

r pl

an,

nati

onal

aw

aren

ess

day

−No

acti

vity

, dra

ft re

port

ing

form

− Reg

ulat

ions

obs

olet

e, u

nder

re vi

sion

. Co

mm

ittee

not

func

tiona

l−−

1212− N

o re

gula

tion

s, or

gani

zed

by d

istr

ibut

ors

(Impo

r ter

s at

(Im

por t

ers

at

own

cost

) ow

n co

st)

−Non

e−O

nly

by d

istr

ibu t

ors,

not

NM

RA−N

o ac

tivi

ty− W

ith

Min

istr

y of

Art

s. N

o re

gu la

tion

s, no

con

trol

in p

ract

ice

−−

1717− N

o PM

S sy

stem

, few

in

spec

tion

sSu

spic

ious

Su

spic

ious

ca

ses

only

ca

ses

only

−N

one

−Non

e−N

ot e

stab

lishe

d− R

egul

atio

ns e

xist

; sys

tem

not

op

erat

iona

l

2525−N

o PM

S sy

stem

−N

one

−Non

e− N

ot e

stab

lishe

d, d

raft

repo

rtin

g fo

rm

exis

ts− I

nfor

mat

ion

mus

t co

rre s

pond

to

MA;

no

t im

plem

ente

d−−

WES

T 0101± 4

5 su

bsta

nces

mon

itor

ed,

depe

ndin

g on

reso

urce

sLa

b no

t in-

Lab

not i

n-vo

lved

(cos

t)vo

lved

(cos

t)−A

war

enes

s pr

ogra

mm

es−N

o sy

stem

−No

regu

lati

ons,

no c

ontr

ol

1313− Q

C La

bora

tory

can

re

ques

t sa

mpl

es. N

o co

ordi

nate

d st

rate

gy

Mar

ket

con-

Mar

ket

con-

trol

mai

n ta

sktr

ol m

ain

task

− Non

e. P

lans

to

set

up a

na

tion

al c

omm

itte

e −N

one

− Not

est

ablis

hed;

dra

ft re

port

ing

form

. No

link

wit

h sp

ecifi

c di

seas

e pr

ogra

mm

es

− App

rova

l by

Min

Pub

lic H

ealth

(but

no

regu

latio

ns);

prom

otio

n ta

rget

ed a

t m

ed. p

rofe

s sio

nals

free

−−

1414±W

eak

syst

em−N

o of

fi cia

l mea

sure

−Adm

in d

ecis

ion

on

dem

and

of m

anu-

fact

urer

/impo

rter

−No

regi

onal

repo

rtin

g st

ruct

ures

± Pro

mot

iona

l mat

eria

l rev

iew

ed f

or

impo

rt p

erm

its

only

; med

i cal

sam

ples

no

t co

ntro

lled

1818± C

olla

bora

tion

wit

h Q

C la

b; P

MS

syst

em n

ot

com

preh

ensi

ve

In c

ase

of

In c

ase

of

susp

icio

nsu

spic

ion

− Med

ia a

war

enes

s pr

ogra

mm

es±C

ircul

ar le

tter

– n

eeds

m

ore

deta

ils−N

o ac

tivi

ty, d

raft

repo

rtin

g fo

rm−N

o re

gula

tion

s−−

1919+ S

am

ple

s co

llec

ted a

nd

test

ed. La

ck o

f in

spec

tors

for

sam

pling

Yes

Yes

− Gre

y ar

eas,

no c

oher

ent

mea

sure

s

+* N

at. p

harm

aco v

igi la

nce

cent

re,

no li

nk w

ith

NM

RA. R

epor

ting

to

WH

O-U

MC

−Not

ope

rati

onal

2222+ S

am

ple

s ta

ken a

long

dis

trib

uti

on c

hain

(esp

ecia

lly

publ.

sect

or)

QC

test

ing

of

QC

test

ing

of

gene

rics

gene

rics

− No

coor

dina

tion

bet

wee

n N

MRA

, cus

tom

s, po

lice

−Non

e− N

o ac

tivi

ty; 1

sta

ff m

embe

r tr

aine

d.

No

link

wit

h di

seas

e pr

ogra

mm

es

− Min

. Pub

. Hea

lth

on a

dvic

e of

co

mm

itte

e (n

ot s

et u

p). N

o co

ntro

l in

pra

ctic

e −−

2323−N

o PM

S sy

stem

Fo

r na

t. pr

o-Fo

r na

t. pr

o-gr

amm

esgr

amm

es−N

one

±Nee

ds c

larifi

cat

ion

− NM

RA a

ssis

ted

by c

omm

itte

e. V

ery

few

repo

rts,

no a

naly

sis.

Not

link

ed to

ot

her p

rogr

amm

es+C

ontr

ol t

akes

pla

ce−−

2424

± Not

ris

k-ba

sed,

no

guid

elin

es o

r SO

Ps;

NM

RA c

anno

t co

ntro

l en

tire

ter

ritor

y

− No

spec

ifi c

prog

ram

me

(Tas

k Fo

rce

exis

ts)

−Pow

er t

o as

k fo

r re

call,

bu

t no

SO

P

+* N

o le

gal b

asis.

Cen

tre

loca

ted

in N

MRA

. Res

ults

sent

to W

HO

UM

C an

d co

nsid

ered

in re

gula

tory

de

cisio

ns.

−Not

ope

rati

onal



AN

NE

X 10

: Con

trol

of

clin

ical

tri

als

= u

nder

the

umbr

ella

of t

he N

MRA

; =

ass

ured

by

anot

her b

ody,

= n

o pr

ovis

ion

in re

gula

tory

sys

tem

Coun

try

Auth

o rit

yG

CP/G

LP

requ

ired

Insp

ec ti

ons

Gap

s / r

emar

ks

EAST 02

No

No

One

app

licat

ion

to d

ate

of v

isit

. No

guid

elin

es, n

o te

chni

cal c

omm

itte

e

03N

oN

oN

o co

ntro

l; no

gui

delin

es f

or a

pplic

ants

. Lac

k of

cap

acit

y an

d no

link

s w

ith

exis

ting

eth

ics

com

mit

tees

(who

se ro

le in

con

trol

ling

CT w

as n

ot c

lear

).

04N

atio

nal a

dvis

ory

com

mitt

ee a

ssis

ts w

ith e

thic

al e

valu

atio

n. N

MRA

lack

s ca

paci

ty.

06--

---

-N

o sy

stem

07N

oN

oEt

hica

l ove

rsig

ht b

y N

at. H

ealt

h In

stit

ute.

No

publ

ishe

d gu

idel

ines

on

GCP

/GLP

, sta

ff n

ot t

rain

ed. N

MRA

con

trol

s pr

oduc

t im

port

atio

n.

09N

oN

oAu

thor

izat

ion

by M

oH. N

o im

port

con

trol

or

GM

P fo

r pr

oduc

ts, n

o re

gula

tion

s

10--

---

-N

o sy

stem

15N

oN

oN

MRA

and

Nat

. Eth

ics

Com

mit

tee.

Tw

o Ac

ts, d

uplic

atio

n of

resp

onsi

bilit

ies.

No

regu

lati

ons/

guid

elin

es. I

nsuf

fi cie

nt e

xper

tise

wit

hin

NM

RA: n

o ac

tivi

ty

16N

oN

oN

MRA

on

advi

ce o

f ac

adem

ic re

sear

ch/e

thic

s co

mm

itte

e. N

o re

gula

tion

s or

gui

delin

es; l

ittl

e ex

perie

nce

in N

MRA

, no

coor

dina

tion

of

tria

ls

20N

oCo

ntro

l by

Min

istr

y of

Sci

ence

& T

echn

olog

y, n

o M

emor

andu

m o

f U

nder

stan

ding

, no

regu

lati

ons

26N

oYe

sAp

prox

. 20

appl

icat

ions

/yea

r. Co

ntro

l thr

ough

Cou

ncil

of S

cien

ce a

nd T

echn

olog

y (2

1 co

mm

it te

es);

NM

RA g

rant

s ap

prov

al a

nd c

ontr

ols

prod

uct

impo

rtat

ion.

Gui

delin

es n

ot in

line

wit

h W

HO

-GCP

sta

ndar

ds

SOU

TH 11Ye

s N

o20

0-30

0 ap

plic

atio

ns p

er y

ear.

Appr

oval

by

prof

essi

onal

cou

ncil;

repo

rtin

g of

out

com

es/a

dver

se e

vent

s to

NM

RA.

21N

oN

oRe

spon

sibi

lity

of N

MRA

, but

in p

ract

ice

cont

rolle

d by

a c

omm

itte

e of

whi

ch N

MRA

is a

mem

ber.

No

ethi

cs c

omm

itte

e to

sup

ervi

se c

linic

al t

rials

.

MID

DLE

05--

---

-To

be

intr

oduc

ed w

ith

new

regu

lato

ry s

yste

m

08N

oYe

sCo

ntro

l by

Hea

lth

Rese

arch

Div

isio

n +N

at.E

thic

s Co

mm

itte

e (n

ot fu

nctio

nal).

Res

pons

ibili

ty t

o gr

ant

appr

oval

not

cle

arly

defi

ned

. NM

RA n

ot in

volv

ed

at a

ll

12--

---

-N

o sy

stem

17

No

No

No

acti

vity

for

eth

ical

revi

ew o

r in

spec

tion

, no

GCP

/GLP

regu

lati

ons

or g

uide

lines

, no

GM

P or

impo

rt c

ontr

ol f

or in

vest

igat

iona

l pro

duct

s

25N

oN

oM

oH re

gion

al c

omm

itte

es, n

o ce

ntra

l ove

rsig

ht. D

raft

regu

lati

ons

only

. No

impo

rt c

ontr

ol o

r G

MP

for

inve

stig

atio

nal p

rodu

cts.

WES

T 01N

oN

o of

fi cia

l str

uctu

re, n

o re

gula

tion

s. Co

ntro

l by

Res.

Ethi

cs C

omm

itte

e, o

f w

hich

NM

RA is

not

a m

embe

r. La

ck o

f ca

paci

ty t

o co

ntro

l clin

ical

tria

ls.

13N

oN

oN

eed

appr

oval

by

MoH

on

advi

ce o

f a

rese

arch

com

mit

tee.

Eth

ics

com

mit

tee

exis

ts b

ut h

as n

o ru

les

of f

unct

ioni

ng. N

o co

ntro

l in

prac

tice

.

14N

oN

MRA

con

trol

s on

ly s

tudi

es c

ondu

cted

in c

onne

ctio

n w

ith

appl

icat

ions

for

MA.

Out

date

d re

gula

tion

s

18N

oYe

sEt

hica

l rev

iew

by

com

mit

tee,

app

rova

l by

MoH

, ins

pect

ion

by N

MRA

and

eth

ics

com

mit

tee.

No

impo

rt c

ontr

ol o

r G

MP

for

inve

stig

atio

nal p

rodu

cts.

19Ye

sN

oLe

gal b

asis

exi

sts.

No

form

ally

defi

ned

eth

ics

com

mit

tee

22N

oN

oN

atio

nal E

thic

s Co

mm

itte

e (n

ot f

unct

iona

l). N

o re

gula

tion

s, no

regi

onal

com

mit

tees

; no

cont

rol i

n pr

acti

ce

23N

oN

oN

atio

nal r

esea

rch

com

mit

tee.

No

impo

rt c

ontr

ol o

r G

MP

(incl

. lab

elin

g) f

or in

vest

igat

iona

l pro

duct

s. N

ew d

raft

regu

lati

ons

not

to W

HO

-GCP

st

anda

rds

24Ye

sYe

sG

uida

nce

avai

labl

e fo

r G

CP; G

MP

men

tion

ed b

ut n

ot re

quire

d fo

r lic

ensi

ng o

f in

vest

igat

iona

l pro

duct

s




References

(Footnotes)

1 Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Korea, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States.

2 Source of classifi cation into geographic regions: Population Division of the Department of Economic and Social Affairs of the United Nations Secretariat (2009), World Population Prospects: The 2008 Revision, http://unstats.un.org/unsd/methods/m49/m49regin.htm#africa. Sudan as the only country of the North region has been included in the East region.

3 Calculated as: Private expenditure on health as proportion of total expenditure on health × Out-of-Pocket expenditure as proportion of private expenditure on health

4 1933 legislation on the practice of pharmacy remains the basic legislative framework; NMRA was constituted by legislation of 1982.

5 A: Government Department , B: Board/Council/Body corporate, C: parastatal agency.

6 ** = Website introduced after visit [11] *** Website no longer found in 2009

(Endnotes)

1 WHO. Effective medicines regulation: ensuring safety, effi cacy and quality. WHO Policy Perspective on Medicines No. 7. Geneva: WHO, 2003. http://apps.who.int/medicinedocs/pdf/s4921e/s4921e.pdf

2 USP. Matrix of Drug Quality Reports in USAID-assisted Countries. By the U.S. Pharmacopeia Drug Quality and Information Program. July 1st, 2008. Available at www.uspdqi.org

3 Caudron JM, Ford N, Henkens M, Macé C, Kiddle-Monroe R, Pinel J. Substandard Medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health. 2008 Aug;13(8):1062-72. http://www.msf.org.za/docs/Scientifi cDocs/TMIH2008_Vol13_substandards.pdf

4 WHO data collection tool for assessment of regulatory authorities. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/assesment/en/index.html

5 WHO. Practical Guidance for Conducting a Review (based on the WHO Data Collection Tool for the Review of Drug Regulatory Systems). Regulatory Support Series, No.12. Geneva: WHO, 2007. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/assesment/en/index.html

6 WHO. World Health Statistics 2009. http://www.who.int/whosis/whostat/2009/en/index.html

7 WHO. Public-Private Roles in the Pharmaceutical Sector - Implications for Equitable Access and Rational Drug Use - Health Economics and Drugs Series, No. 005. Geneva: WHO, 1997.

8 Ratanawijitrasin S, Wondemagegnehu E. Effective drug regulation: A multicountry study. Geneva: WHO, 2002. apps.who.int/medicinedocs/collect/medicinedocs/pdf/s7916e/s7916e.pdf

9 WHO. Guidelines for registration of fi xed-dose combination medicinal products. Annex 5. In: WHO Technical Report Series No. 929, 2005. http://whqlibdoc.who.int/trs/WHO_TRS_929_eng.pdf

10 WHO. National policy on traditional medicine and regulation of herbal medicines. Report of a WHO global survey. Geneva: World Health Organization, 2005. http://apps.who.int/medicinedocs/collect/medicinedocs/pdf/s7916e/s7916e.pdf

11 WHO. List of Globally identifi ed Websites of Medicines Regulatory Authorities (as of November 2009). http://www.who.int/entity/medicines/areas/quality_safety/regulation_legislation/ListMRAWebsites.pdf

12 WHO. Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: A manual for drug regulatory authorities. Geneva, World Health Organization, 1999 (Regulatory Support Series, No. 5) (WHO/DMP/RGS/98.5). www.who.int/prequal/info_general/documents/WHO_DMP_RGS_98_5_R.pdf

13 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Annex 7. In: WHO Technical Report Series No. 937, 2006. http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf

14 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Guidelines for organizations performing in vivo bioequivalence studies. Annex 9. In: WHO Technical Report Series No. 937, 2006. http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf



15 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Guidelines for implementation of the WHO certifi cation scheme on the quality of pharmaceutical products moving in international commerce. Annex 10. In: WHO Technical Report Series No. 863, 1996. Current version of the guideline available at: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certifi cation/en/

16 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Procedure for prequalifi cation of pharmaceutical products. Annex 3. In: WHO Technical Report Series, No. 953, 2009. http://www.who.int/medicines/publications/pharmprep/pdf_trs953.pdf#page=164

17 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Good manufacturing practices for pharmaceutical products: main principles. Annex 4. In: WHO Technical Report Series, No. 908, 2003. whqlibdoc.who.int/trs/WHO_TRS_908.pdf

18 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Guide to good storage practices for pharmaceuticals. Annex 9. In: WHO Technical Report Series No. 908, 2003. whqlibdoc.who.int/trs/WHO_TRS_908.pdf

19 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. WHO good distribution practices for pharmaceutical products. Annex 5. In: WHO Technical Report Series No. 957, 2010. www.who.int/entity/medicines/publications/TRS957_2010.pdf

20 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. WHO good pharmacy practice in community and hospital pharmacy settings. Annex 7. In: WHO Technical Report Series No. 885. Geneva, World Health Organization, 1999.

21 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Quality systems requirements for national good manufacturing practice inspectorates. Annex 8. In: WHO Technical Report Series, No. 902, 2002. http://apps.who.int/prequal/info_general/documents/TRS902/WHO_TRS_902-Annex 8.pdf

22 International Organization for Standardization. ISO/IEC 17025:2005. General requirements for the competence of testing and calibration laboratories. Geneva: ISO, 2005.

23 UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR). Handbook: Good laboratory practice (2nd edition). Quality practices for regulated non-clinical research and development Geneva, 2009. www.who.int/tdr/svc/publications/training-guideline-publications/good-laboratory-practice-handbook

24 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. WHO good practices for pharmaceutical quality control laboratories. Annex 1. In: WHO Technical Report Series No. 957, 2010. www.who.int/tdr/svc/publications/training-guideline-publications/good-laboratory-practice-handbook

25 WHO fact sheet on counterfeiting. Key facts. July 2009. http://www.who.int/medicines/services/counterfeit/CfeitsFactSheetJuly09.pdf

26 World Medical Association. Declaration Of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, as amended by the 59th WMA General Assembly, Seoul, October 2008. http://www.wma.net/en/30publications/10policies/b3/index.html

27 WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Annex 3. In: WHO Technical Report Series No. 850, 1995. http://www.who.int/medicinedocs/collect/medicinedocs/pdf/whozip13e/whozip13e.pdf

28 OMS, Comité Régional de l’Afrique. Cinquante-sixième session, Addis-Abéba, Ethiopie, 28 août – 1er septembre 2006. Autorités de réglementation pharmaceutique: situation actuelle et perspectives. Rapport du Directeur régional. www.afro.who.int/rc56/documents/french/afr_rc56_11_autorites_reglement_pharmaceutique.pdf

29 FIP. 2009 FIP Global Pharmacy Workforce Report. www.fi p.org/www/index.php?page=menu_resourcesforhealth

30 South African Health Review 2003/04. Chapter 22: Human resources. Durban: Health Systems Trust, 2004.

31 Conférence Internationale des Ordres de Pharmaciens Francophones (CIOPF). Fiches des pays. http://www.ciopf.org/fi ches_des_pays/

32 Medicine Prices in Ghana: A comparative study of Public, Private and Mission sector medicine prices. Accra: Ghana Health Service, Ministry of Health, 2006.



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average exchange rate

hr dev plan

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