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WHO efforts to promote good regulatory and good reliance practices Samvel Azatyan MD, PhD. Acting Coordinator Regulatory Systems Strengthening [RSS] Regulation and Prequalification Department [RPQ] World Health Organization E-mail: [email protected] 1 Improving the Response of Global Public Health in a Fast-changing World Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers of in-vitro diagnostic products, vaccines & immunization devices, finished pharmaceutical products, active pharmaceutical ingredients, contraceptive devices and vector control products 2−5 December 2019, UN City, Copenhagen, Denmark
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t,K ( ( } } } u } P } } P µ o } Ç v P } } o ] v ] · 2019-12-04 · t,K ( ( } } } u } P } } P µ o } Ç v P } } o ] v ] ^ u À o Ì Ç v D U W Z X: } ] v hE/ & U hE&W v t,K u ]

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Page 1: t,K ( ( } } } u } P } } P µ o } Ç v P } } o ] v ] · 2019-12-04 · t,K ( ( } } } u } P } } P µ o } Ç v P } } o ] v ] ^ u À o Ì Ç v D U W Z X: } ] v hE/ & U hE&W v t,K u ]

WHO efforts to promote good regulatory and good reliance practices

Samvel Azatyan MD, PhD.Acting CoordinatorRegulatory Systems Strengthening [RSS]Regulation and Prequalification Department [RPQ]World Health OrganizationE-mail: [email protected]

1

Improving the Response of Global Public Health in a Fast-changing WorldJoint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers of in-vitro diagnostic products, vaccines & immunization devices, finished pharmaceutical products, active pharmaceutical ingredients, contraceptive devices and vector control products2−5 December 2019, UN City, Copenhagen, Denmark

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Access to medical products – global challenge

• In many low- and middle-income countries essential medicines are not always readily available and accessible;

• WHO estimate is that one third of the world’s population have no access to essential medicines (and more than half in some areas);

• Lack of essential medicines contributes to disparities in health and life-expectancy between low-income and high-income countries;

• Reasons for limited/insufficient access are different but one of them is inadequate regulatory capacity and lack of collaboration and work sharing in medicines regulation.

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

It is all about the time..

3

One child under age 15 died every five seconds in 2018UN Inter-agency Group for Child Mortality Estimation

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

WHA Resolutions: WHA 67.20 (2014); WHA 67.21 (2014); WHA63.12 (2010)

• All pharmaceutical products, including multisource products, should be used in a country only after approval by the national or regional regulatory authority.

• Regulatory authorities should require the documentation of a multisource pharmaceutical product to meet the following:

• GMP;• Quality requirements; and• Pharmaceutical product interchangeability

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Medicines Regulation Process Flow (1)

5

Manufacturers (Mx)

Rejected (Rj)

Approved (Rx)NRA

Standards & requirements

Processes

Laws & Regulations

HR capacity

QMS

Variations

Withdrawn (Rw)

Post-registration monitoring

R(p)

IDEAL SITUATION

Healthier populations

Robust Registration Systems

Page 6: t,K ( ( } } } u } P } } P µ o } Ç v P } } o ] v ] · 2019-12-04 · t,K ( ( } } } u } P } } P µ o } Ç v P } } o ] v ] ^ u À o Ì Ç v D U W Z X: } ] v hE/ & U hE&W v t,K u ]

Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Medicines Regulation Process Flow (2)

6

Manufacturers (Mx)

Rejected (Rj)

Approved (Rx)NRA

Standards & requirements

Processes

Laws & Regulations

HR capacity

QMS

Variations

Withdrawn (Rw)

Post-registration monitoring

R(p)

REAL SITUATION

Registration processes not optimized

Page 7: t,K ( ( } } } u } P } } P µ o } Ç v P } } o ] v ] · 2019-12-04 · t,K ( ( } } } u } P } } P µ o } Ç v P } } o ] v ] ^ u À o Ì Ç v D U W Z X: } ] v hE/ & U hE&W v t,K u ]

Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Gap in Regulatory Capacity

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

• Regulatory capacity gap between different countries (low- and high-income) in terms of:

• Human and financial resources;• Regulatory functions effectively performed;• Expertise available for fulfilling regulatory functions;• Availability of proper systematic training for regulators;• Applying quality management principles.

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Need for reliance – LMIC example

Summary observations:• Guidelines and assessment procedures are

not up to international standards and are often of an administrative rather than technical nature;

• Inadequate resources severely limit technical assessment of dossiers;

• In spite of resource constraints only few countries rely/refer on decisions made by other regulators (such as stringent NMRAs or by the WHO PQ);

• Some countries had restrictive regulations not allowing reliance..

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26 country study

in Africa

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

The concept of regulation is changing (1)

NRAs are mandated in their jurisdictions to ensure timely access to safe, effective and quality medical products - in line with international standards;

There is no clear vision or policy about HOW to set up regulatory systems in times when it is unrealistic to manage all functions in one national setting for most regulators – globalization of regulatory science;

New products are likely more complex and sophisticated – demanding advanced health systems and "quality use“;

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

The concept of regulation is changing (2)

Questions to answer: Can all national regulators assess and inspect all

product applications coming to their markets? Does repetitive assessments and inspections give

any added value? If they prefer not to repeat the work done - how to

build confidence in scientific assessments/ inspections carried out by other parties?

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

The concept of regulation is changing (3)

Health systems and health providers are varying in “strength” between countries:

• Not all new products coming to the markets equally fit for all types of health systems and health providers available;

• Benefit/risk assessment is not always taking into consideration the health systems in which product is to be launched?

• Not always we know what exact competencies are needed for regulators to be able to perform their functions.

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Draft WHO GRP Guidelines

• The guideline outlines internationally accepted principles of GRP and describes how they may be implemented;

• Is intended for NRAs and other related institutions responsible for the formulation of health policies, laws, regulations and guidelines;

• Will assist WHO Member States in the implementation of GRP, both in establishing new regulatory systems for medical products and in improving the existing ones.

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Framework of Best Practices for Regulation of Medical Products

GRP Umbrella Statement

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Performance Measurement

Good Reliance Practices

Good Review

Practices

Regulatory Pathways –Good Registration

Practices

Good Guidance Practices

Good Governance

Practices

QMS for Regulatory Authorities

Global Regulatory

Model

Models for Regulatory

Systems

Good Regulatory Practices

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Good reliance practices guideline

Scope:• The guideline is intended for national regulatory authorities and

to be applied across processes involving the regulation of pharmaceuticals products, including small molecule, biologics and vaccines;

• These processes and their respective frameworks and policies include, but are not limited to:

• the management of clinical trial applications,• product applications• post-approval activities.

Format of the document:• Expected to be a light and practical instrument – deriving from

the “parent” GRP guideline

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Reliance facilitates good quality decisions:WHO efforts • Promoting good governance and transparency in medical

products sector – GRP process;• Promoting and facilitating building up national regulatory

systems as part of overall health systems strengthening;• Promoting functional/adequate national regulatory systems

as important contributor to achieving universal health coverage and able to address public health priorities;

• Supporting regulatory workforce development – Global Regulatory Curriculum;

• Promoting regulatory cooperation, convergence and harmonization;

• Promoting work sharing – based on reliance on the work of trusted authorities to inform regulatory decision-making.

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Timely access to medical products – never-ending challenge • Patients/consumers – wherever they are – deserve access to

quality assured medical products with positive benefit-risk characteristics - UHC;

• Today’s reality and demand: to generate quality national decisions regulators globally MUST collaborate and MUST take into consideration the information available from other regulatory authorities;Not using the outputs and outcomes from other regulatory

authorities

Lost opportunity, duplication of efforts, increased regulatory burden and waste of scarce resources

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Options for achieving a regulatory decision

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Unilaterial or mutual recognition: mutual recognition is based on treaties or equivalent, providing maximal benefits but partial loss of sovereignty with regard to decision-makingRecognition

Reliance on regulatory decisions performed by other competent and trusted agencies and/or cooperation/collaboration with other regulators to reduce the workload, with independent final decision-making

Reliance

Work-sharingJoint reviews

NRA makes independent decisions based on its own reviews or inspections

Normal/standard process

Regulatory cooperation based on convergence/ harmonization to improve the quality of decision making process

WHA resolution 67.20 (2014)

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Regulatory cooperation hierarchy

18

Convergence &

harmonization

Convergence &

harmonization

Recognition

Reliance

Work-sharing

Information-sharing

Reliance

Reliance

Recognition

Recognition

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Reliance and Recognition

Often-used terms in regulatory documentation, but lack formal definition

• Reliance: is the act whereby a regulatory authority in one jurisdiction may take into account and give significant weight to evaluations performed by another NRA or other trusted institution for reaching its own decision. The relying authority remains responsible and accountable for decisions taken, even when it relies on the decisions and information of others.

• Recognition: the routine acceptance by the NRA in one jurisdiction of the regulatory decision of another NRA or other trusted institution. Indicates that there is a sufficient evidence of conformity with the regulatory requirements of country A to meet the regulatory requirements of country B.

• In all cases the sovereignty of regulatory decision remains in the hands of national regulators.

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Registration Pathways available for NRAs

20

Decisions based on information generated

(100%) by NRA

Verification, Secondary or tertiary reviews of primary reports from other agencies e.g. “SRA” or WHO PQ

e.g. EU decentralized procedure, ZAZIBONA

e.g. Reference NRAs, WHO PQ, EU Mutual recognition.

Work-sharing

Joint activities

e.g. EU centralised procedure, WHO-EAC joint

assessments

Reliance

NRA capabilities

Recognition

Full assessment

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

When can reliance be used?

Some elements of regulatory oversight can be shared • Evaluation of quality, efficacy and safety;• Inspections;• Testing.Other elements of regulatory oversight must be local• Licensing decision;• Local manufacturing oversight;• Pharmacovigilance;• Appropriate distribution controls (stability and cold

chain)• Product security.

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Facilitated pathways to “transfer” regulatory information & knowledge

22

WHO collaborative

procedureVaccines: 2004

Medicines: Started in 2012Diagnostics: Pilot 2019

Vector control: Pilot 2020

“SRA” collaborative procedure

• Sharing information / expertise (assessment, inspection and testing results or expertise) that serve as basis for national decisions – avoiding duplication.

• Voluntary participation – reference authorities, participating authorities and manufacturers/sponsors

Initiated in 2015European Medicines

Agency (EMA)Medicines and

Healthcare Products Regulatory Agency

(MHRA)20 African NRAs

Regional networks

PRINCIPLES

African Medicines Regulatory

Harmonization Project (AMRH)

ASEAN SIAHR Project

**CRP-lite

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

IDEAL SITUATION – with facilitated pathways

23

Manufacturers (Mx)

Rejected (Rj)

Approved (Rx)NRA

Standards & requirements

Processes

Laws & Regulations

HR capacity

QMS

Variations

Withdrawn (Rw)

Post-registration monitoring

R(p) Healthier populations

Reliance

Normal

Joint / Work-sharing

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

Conclusions:

• Not a single regulator anymore can fulfil all regulatory work alone;

• The future of medical products regulation is in convergence/harmonization, collaboration, work-sharing and networking – based on reliance;

• Regulators are starting to operate more as a functional network rather than individual players, and individual players focusing on where they can give the best added value;

• The new “regulatory work-sharing slogan” could be:

Do yourself only what you can do well,and benefit from what others could do better..

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Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers2−5 December 2019, UN City, Copenhagen, Denmark

www.who.int/medicines

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