1 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals WHO’s Role in Assuring the Quality Safety and Efficacy of Medicines:

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Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals

WHO’s Role in Assuring the WHO’s Role in Assuring the Quality Safety and Efficacy of Quality Safety and Efficacy of

Medicines:Medicines:

IntroductionIntroduction

Lembit Rägo, MD, PhD Coordinator, Quality Assurance and Safety: Medicines (QSM)

Acting Coordinator, Quality Assurance and Safety: Blood Products and Related Biologicals (QSD)

Essential Drugs and Medicines Policy Health Technology and Pharmaceuticals Cluster

World Health OrganizationE-mail: [email protected]

EDM Technical Briefing 2006

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This block of presentations gives

General introduction to quality and safety issues Detailed overview of WHO's normative activities in the

area of medicines (excluding biologicals) quality (QSM) Introductory presentation on the area of quality assurance

and safety of blood products and related biologicals (QSD)

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The rest of the QSM activities

Later in the programme Prequalification Safety - Pharmacovigilance

Not covered by this training course INN programme ATC/DDD classification and its use Scheduling controlled substances and access to controlled

medicines …

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Standards for medicines

How to judge that medicines are what we expect them to be?

In case of many products people take their judgements at least partly based on what they see, smell or taste …or hear

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Usual perceptions may not help to make judgments about medicines …

SmellAppearance Taste

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In case of medicines they all look nice, mostly do not have any smell, some may have bad taste…and are increasingly marketed even through internet (see example below, note that selling medicines via internet may be illegal and products may be counterfeit or substandard)

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Why medicines are special category of products?

Consumers, patients and health care workers have limited capacity to judge there

SAFETY QUALITY EFFICACY

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Are all medicines safe, effective and meet quality criteria?

No, they are not

Some are safe, but not effective or necessarily meet the quality criteria

Some may be effective, meet quality criteria but are not safe

Some meet quality criteria but are not necessarily safe or have any efficacy

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Quality - Safety

Some safety parameters are determined by quality

Some safety parameters are determined by the intrinsic properties of active pharmaceutical ingredient

However, in fact QUALITY in general perception (and often in policy documents) is incorporating also expectations for efficacy and safety without necessarily saying so

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What type of medicines we have?

Originator products

Multisource (generic) products

KEY – INTERCHANGEABILITY, more important THERAPEUTIC INTERCHNGEABILITY

ALL LITERATURE IS BASED ON ORGINATORS

No interchangeability – NEED FOR NEW SAFETY and EFFICACY DATA, NEW BOOKS HAVE TO BE WRITTEN

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What type of regulations exist and how they differ?

For innovator products proof of QUALITY, SAFETY and EFFICACY is needed

For multisource products QUALITY, safety and efficacy data is referred to the originator providing only evidence about interchangeability (bioequivalence, clinical testing, in limited cases dissolution data)

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Regulations: Global vs National

National regulations still differ a lot

What is ICH and what it is not?

Regional harmonization initiatives

Do global norms exist for generics?

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Who sets the standards?Is the WHO Involved?

WHO has the unique mandate to set standards

WHO Constitution (Chapter II, Article 2), inter alia, states (6): In order to achieve its objective, the

functions of the organization shall be:… to develop, establish and promote

international standards with respect to food, biological, pharmaceutical and similar products;

Example of WHO work from 1966

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Is quality of medicines a problem?

Yes, a HUGE problem

If we would have the same compliance with norms and quality in aircraft industry Globally as we have with medicines, perhaps

approximately 25% planes would not take off the grounds

(no or very poor treatment effect, can also potentially kill if disease deadly)

5-10% would crash and injure or kill the people (toxicity, severe adverse reactions etc. )

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What WHO is doing?

Norms and standards, nomenclatures International Pharmacopoeia International Nonproprietary Names (INN) ATC/DDD classification …

Regulatory guidelines Good Manufacturing Practice; Good Clinical Practice etc. Comprehensive set of guidelines for registering generic drugs …

Information exchange WHO Drug Information (quarterly) WHO pharmaceutical Newsletter WHO Rapid Alerts International Conference of Drug Regulatory Authorities (ICDRA) – usually more than 100

countries represented ….

Capacity building and training GMP training courses Courses on how to assess generic drugs Courses on pharmacovigilance ….

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Conclusions

A lot of good work ongoing but …. Limited capacity to advertise, promote, inform etc. Limited resources to build capacity in countries

Please, for more information:http://www.who.int/medicines

Documents

1 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals WHO’s Role in Assuring the Quality Safety and Efficacy of Medicines: