Transcript WHO`s Role in Assuring the Quality Safety and

WHO’s Role in Assuring the Quality
Safety and Efficacy of Medicines:
Introduction
EDM Technical Briefing 2006
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 Organization
E-mail: [email protected]
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
1
This block of presentations gives
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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)
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
2
The rest of the QSM activities
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Later in the programme
 Prequalification
 Safety - Pharmacovigilance
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Not covered by this training course
 INN programme
 ATC/DDD classification and its use
 Scheduling controlled substances and access to
controlled medicines
 …
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
3
Standards for medicines
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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
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
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Usual perceptions may not help to make
judgments about medicines …
Appearance
Smell
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
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Taste
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)
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
6
Why medicines are special category of
products?
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Consumers, patients and health care workers have limited
capacity to judge there
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SAFETY
QUALITY
EFFICACY
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
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Are all medicines safe, effective and meet
quality criteria?
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No, they are not
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Some are safe, but not effective or necessarily meet the
quality criteria
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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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Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
8
Quality - Safety
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Some safety parameters are determined by quality
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Some safety parameters are determined by the intrinsic
properties of active pharmaceutical ingredient
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However, in fact QUALITY in general perception (and
often in policy documents) is incorporating also
expectations for efficacy and safety without necessarily
saying so
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
9
What type of medicines we have?
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Originator products
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Multisource (generic) products
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KEY – INTERCHANGEABILITY, more important
THERAPEUTIC INTERCHNGEABILITY
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ALL LITERATURE IS BASED ON ORGINATORS
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No interchangeability – NEED FOR NEW SAFETY and
EFFICACY DATA, NEW BOOKS HAVE TO BE
WRITTEN
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
10
What type of regulations exist and how they
differ?
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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)
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
11
Regulations: Global vs National
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National regulations still differ a lot
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What is ICH and what it is not?
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Regional harmonization initiatives
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Do global norms exist for generics?
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
12
Who sets the standards?
Is the WHO Involved?
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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;
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
13
Example of WHO
work from 1966
Is quality of medicines a problem?
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Yes, a HUGE problem
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If we would have the same compliance with norms and
quality in aircraft industry Globally as we have with
medicines, perhaps
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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. )
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
14
What WHO is doing?
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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
….
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
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Conclusions
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A lot of good work ongoing but ….
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Limited capacity to advertise, promote, inform etc.
Limited resources to build capacity in countries
Please, for more information:
 http://www.who.int/medicines
Department of Medicines Policy and Standards,
Health
Technology and Pharmaceuticals
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