Building capacity in countries to improve the regulation ......Building capacity in countries to improve the regulation of medical products ... regulations Increased access to quality

Building capacity in countries to improve the regulation of medical

products

Annual Technical Briefing Seminar Essential Medicines and Health Technologies

Dr Claudia P Alfonso Regulatory Systems Strengthening Team Regulation of Health Technologies Unit

Department of Essential Medicines and Health Products

20 October 2016, Geneva, Switzerland

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2 | WHO/EMP/RHT/RSS

Objective

– Build capacity for professional staff (mainly pharmacists) in the area of pharmaceuticals

Audience

– Ministry of Health, National Regulatory Authorities, WHO Regional and Country Offices, Collaborating Centres, Non-Governmental

Organizations, Academia, and others, from all continents

Expected outcome – By end of presentation, the audience became informed on the WHO

NRA capacity building model to improve in-country regulation of

medical products

Technical Briefing Seminar

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3 | WHO/EMP/RHT/RSS

Medical products shall refer to medicines, biologicals including vaccines, and medical devices including diagnostics

National regulatory authority (NRA) also called National Medicinal Regulatory Authority (NMRA) shall refer to the agency, institution or body authorized by law to exercise regulatory powers concerning the registration of, and other regulatory activities related to, medical products

Regulatory system shall refer to the combination of institutions, processes and the regulatory framework through which government controls particular aspects of an activity

Definitions

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4 | WHO/EMP/RHT/RSS

The global context

behind the WHO NRA

capacity building model to

improve in-country

regulation of medical

products

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5 | WHO/EMP/RHT/RSS

WHO Constitution*

“The States Parties to this Constitution declares …

The enjoyment of the highest attainable standard of health is one of the fundamental rights of

every human being without distinction of race, religion, political belief, economic or social

condition“

WHO Constitution, Chapter II – Functions, Article 2 (c)

* Adopted by the International Health Conference, 19 Jun-22 Jul 1946, New York. Signed by the representatives of 61 States on 22 Jul 1946. Entered into force on 7 Apr 1948

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6 | WHO/EMP/RHT/RSS

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7 | WHO/EMP/RHT/RSS

Alignment of EMP strategic direction, WHO reform, and WHA 67.20 on regulatory systems strengthening

WHO leadership priorities 2014-2019 (WHA66):

Advancing universal health coverage Health-related MDG Address challenges of non-

communicable diseases Implement international health

regulations Increased access to quality and

affordable medical products Social, economic and environmental

determinants of health

7

At the request of Member States, WHO is to:

Evaluate national regulatory systems;

Apply WHO evaluation tools; Generate and analyze evidence

of regulatory system performance;

Facilitate the formulation and implementation of institutional development plans; and,

Provide technical support to national regulatory authorities and governments

WHA

67.20

WHA 67.22

WHA

67.21

WHA 67.23

WHA

67.18 Others

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8 | WHO/EMP/RHT/RSS

Norms and standards

Capacity building in developing

countries Networks

Medical devices including

diagnostics ICDRA

WHO

PQ program

Health system

strengthening

International and regional

collaboration

Regulation of complex

biological

WHA Resolution 67.20 Regulatory Systems Strengthening

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9 | WHO/EMP/RHT/RSS

Achieve universal health coverage

(UHC), including financial risk protection, access to quality essential

health care services, and access to safe, effective, quality, and affordable

essential medicines and vaccines for all

Unifying purpose Sustainable development goal 3.8

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10 | WHO/EMP/RHT/RSS

GLOBAL OVERVIEW

Facts and figures

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Current Status of National Regulatory Systems 194 WHO Member States

Fact

• ≈30% of NRA have limited capacity to perform core regulatory functions

• Applicants face a landscape of disparate regulations, frequent delays, and limited transparency

Result

• Fewer medicines are available in low-income countries than in the countries with well-regulated markets

• Cost of inefficient regulatory systems drives medicines price up

• Less prepared for public health emergencies i.e. Ebola, Zika, pandemic influenza

20% 50%

30% Developed

Variable

Limited

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Vaccine producing

1990: 63 countries

2016: 43 countries

Vaccine demand increased, number of producing countries decreased 1990-2016

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Number of WHO Member States according to vaccine source and regulatory functionality status as of May 2016

Vaccine source Functional Not

functional Grand Total

Domestic production 37 6 43

Direct procurement 20 28 48

UN agency 9 94 103

Grand Total 66 128 194

14 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group

Regulatory capacity Countries sourcing vaccine from UN agencies (N = 14)

© World Health Organization 2014 14

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THE WHO REGULATORY CAPACITY BUILDING MODEL

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The WHO five-step capacity building model for National Regulatory Authorities

Bench marking tool development

NRA assessments

Elaboration of

institutional development

plan (IDP)

Providing technical, training,

learning, and networking

support

Monitoring progress and

impact

Min

ima

l c

ap

ac

ity

me

t,

Va

cc

ine

s:

eli

gib

ilit

y f

or

PQ

1 2 3 4 5

Plan and conduct periodic assessments, re-assessments, and

self assessments

Periodic refinement and harmonization

of tools, indicators and

assessment process

Detailed plan of

action to sustain strengths and address gaps

IDP implementation

through technical expertise, global

learning opportunities, in-country training

Document NRA

information, assessment reports,

IDP, trainings, experts, impact,

others

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BENCHMARKING


WHO Global Benchmarking Tool National Regulatory System and Functions

1. Regulatory System 2. Common Function 3. Non Common Functions

SYSTEM FUNCTION

INDICATORS

SUB-INDICATORS

GUIDANCE FOR ASSESSMENT Assessment Criteria + Standrad References + Evidences For Review

Common Function Non Common Functions

01-NATIONAL REGULATORY SYSTEM 02-REGISTRATION AND MARKETING AUTHORIZATION 03-VIGILANCE

04-MARKET SURVEILLANCE AND CONTROL 05-LICENSING PREMISES 06-REGULATORY INSPECTION 07-LABORATORY ACCESS AND TESTING 08-CLINICAL TRIAL’S OVERSIGHT

09-NRA LOT RELEASE

1. WHO Guidelines 2. Other Internationally recognized guidelines

(e.g. ISO standards) 3. Identified best practiced


WHO Global Benchmarking Tool Scoring System

SYSTEM

FUNCTION

INDICATORS

SUB-INDICATORS

GUIDANCE FOR ASSESSMENT Assessment Criteria + Standrad References + Evidences For Review

Yes

No

Partial

Not Applicable

No Available Info.

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NRA ASSESSMENT

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WHO NRA Benchmarking Policy Periodic assessments


WHO Global Benchmarking Tool


NRA assessment report

24 |

INSTITUTIONAL DEVELOPMENT PLAN


Institutional Development Plan

26 |

TECHNICAL SUPPORT


Gap analysis

• Assessment report

Institutional Development

Plan

• Recommendations and activities to sustain strengths and address gaps within cost estimate and time frame

Address gaps

• Targeted regulatory functions • Technical support • Learning/ training/ international

cooperation opportunities


impact

• Follow-up visit to measure progress and impact

• Re-assessment to sustain PQ or NRA functionality until expected maturity is achieved

From gap analysis to building capacity

Global Learning

Opportunities

In-county workshops

One-site technical support

Placement, joint

reviews, twining

Regulatory functions targeted:

1. NATIONAL REGULATORY SYSTEM

2. REGISTRATION AND MARKETING AUTHORIZATION

3. LICENSING OF PREMICES

4. MARKET SURVEILLANCE AND CONTROL

5. VIGILANCE

6. REGULATORYINSPECTIONS

7. CLINICAL TRIALS OVERSIGHT

8. LABORATORY ACCESS AND TESTING

9. NRA LOT RELEASE

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Regulatory capacity building Non-vaccine producing countries (N = 14)

© World Health Organization 2014 28

Regional and in-country QMS workshops; GRP guidelines

Product evaluation training, collaborative procedure workshops, regional harmonization, WHO guidelines

Overseas and in-country training on medical product safety and vigilance, ADR and AEFI monitoring and reporting guidelines

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MONITORING PROGRESS AND IMPACT

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WHO NRA Benchmarking Policy Periodic assessments


WHO technology transfer to establish influenza vaccine manufacturing capacity NRA assessment for vaccine pre- qualification

Measuring and showing impact

WHO

Region

Global Action Plan for

Influenza Vaccines

country*

NRA functional**

2006 2016

AFR South Africa 0 0

AMR Brazil, Mexico Brazil Brazil, Mexico

EMR Egypt, Islamic Rep. Iran 0 Egypt, Iran

EUR Serbia, Romania,

Kazakhstan 0 0

SEAR India, Indonesia, Thailand Indonesia, India India, Indonesia,

Thailand

WPR China, Rep. Korea, Viet

Nam Rep. Korea

China, Rep.

Korea, Vietnam

Total 4/14 (29%) 10/14 (71%)

*http://www.who.int/influenza_vaccines_plan/objectives/projects/en/index.html **Vaccine producing countries, http://workspace.who.int/sites/ATT/default.aspx

http://www.who.int/influenza_vaccines_plan/objectives/projects/en/index.html


The WHO five-step capacity building model for National Regulatory Authorities

Bench marking tool

development

NRA assessments

Elaboration of institutional development

plan (IDP)

Providing technical, training,

learning, and networking

support


impact

Acc

ep

tab

le c

apa

city

me

t, V

acci

ne

s:

elig

ibili

ty f

or

PQ

1 2 3 4 5

Plan and conduct periodic assessments, re-assessments, and

self assessments

Periodic refinement and harmonization

of tools, indicators and

assessment process

Detailed plan of

action to sustain strengths and address gaps

IDP implementation

through technical expertise, global

learning opportunities, in-country training

Document NRA

information, assessment reports,

IDP, trainings, experts, impact,

others


• How many and which steps does the WHO regulatory capacity building model have?

• What medical products as well as common and uncommon functions can be assessed using the WHO Global benchmarking tool?

• How often should an NRA be benchmarked?

• For what does IDP stand?

• What support does WHO provide for IDP implementation?

• How long should investment by all partners be sustained to see impact?

Quick quiz on the WHO NRA capacity building model to improve in-country regulation of medical products

Gracias

Building capacity in countries to improve the regulation ......Building capacity in countries to improve the regulation of medical products ... regulations Increased access to quality

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