Transcript WHO`s Normative Work in the Field of

WHO’s Normative Work in the Field
of Pharmaceuticals - introduction
November 2003
Lembit Rägo, MD, PhD, Coordinator
Quality Assurance and Safety: Medicines
Essential Drugs and Medicines Policy
Health Technology and Pharmaceuticals Cluster
World Health Organization
E-mail: [email protected]
Why normative work is needed?
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Medicines are very specific category of products
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Patients/consumers limited capacity to assess their safety, efficacy
and quality
Pharmacists and medical doctors - the same
Medicines must meet three basic criteria
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SAFETY
EFFECACY
QUALITY
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Meeting with FDA, Mar. 2002
To assess QUALITY, SAFETY and EFFICACY
norms and standards are needed
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New innovative medicines (NCE or NDA)
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QUALITY, SAFETY; EFFICACY
Multisource or generic medicine
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QUALITY, and proof of being therapeutically interchangeable
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Meeting with FDA, Mar. 2002
WHO medicines strategy
Normative work on pharmaceuticals - Health
Technology and Pharmaceuticals Cluster
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Essential Drugs and Medicines Policy
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Quality Assurance and Safety: Medicines (QSM)
Policy, Access and Rational Use (PAR)
Drug Action Programme (DAP)
Traditional Medicine (TRM)
Vaccines and Biologics - in another cluster FCH
Blood Safety and Clinical Technology - Now Essential
Technologies
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Meeting with FDA, Mar. 2002
Quality Assurance and Safety: Medicines Team
(QSM) --- areas of work
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Norms, standards and guidelines for quality, safety
and efficacy of pharmaceuticals
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Nomenclatures, classifications
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International Nonproprietary Names (INNs)
Anatomical Therapeutic Chemical (ATC) classification and Defined Daily
Dose (DDD)
Guidance for control and use of psychotropics and
narcotics
Drug safety
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International Pharmacopoeia, GMP, GCP etc.
The WHO Programme for International Drug Monitoring etc.
Drug regulatory support
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WHO Certification Scheme, assessment of NDRAs, training for
regulators etc.
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Norms and standards for pharmaceuticals
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International Pharmacopoeia
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Basic tests
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Simple, classical physicochemical techniques are used
Priority given to essential drugs, especially to drugs that are
important to WHO health programmes (anti-TB etc.)
Based on international experience and tested in WHO
Collaboration Centres
Limited range of widely available reagents are used
Can be applied when a fully equipped laboratory is not
available
Merely confirm identity, does not replace pharmacopoeial
monograph
Reference substances and infrared reference
spectra for pharmacopoeial analysis
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Meeting with FDA, Mar. 2002
Guidelines for pharmaceuticals
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Good Manufacturing Practices (GMP)
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including starting materials --> would be revised based on ICH
Q7A. Step-wise approach to the implementation needed
including specific products (sterile, biological, investigational,
and herbal products) --> guidelines for radiopharmaceutical
products newly adopted at the Expert Committee
Model certificates adopted
Guidance for GMP inspection report adopted
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Inspection of manufactures and distribution
channels
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Good Storage Practices
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Adopted at the Expert Committee
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Meeting with FDA, Mar. 2002
Guidelines for pharmaceuticals
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Good Clinical Practice (GCP)--- under revision
Development of ICH GCP
 Significant changes were made to Declaration of Helsinki (5th
amendment in 2000)
 Publication of EU Directive on GCP in April 2001
 Needs for harmonization
 Ethical aspects should be strengthened
--> Informal consultation to review WHO GCP was held in
September 2001
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Drug Regulatory Support
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WHO Certification Scheme
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on the quality of pharmaceutical products
on the quality of starting materials
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Assessment of NDRAs --> “evidence based”
interventions and training for regulators
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WHO Basic Training Modules on GMP
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Medical Products and the Internet: A Guide to
Finding Reliable Information
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Training workshop for inspectors
Guide to consumers
Model web site for drug regulatory authorities
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Meeting with FDA, Mar. 2002
Drug Regulatory Support
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International Conference of Drug Regulatory
Authorities (ICDRA)
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Promotion of regulatory harmonization
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promoting collaboration and exchange of information between
DRAs
discussing common regulatory challenges
acting as a link between ICH and non-ICH countries
regional harmonization (PAHO, ASEAN etc.)
SIAMED (computer-assisted drug registration
system)
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jointly developed with PAHO
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Meeting with FDA, Mar. 2002
Drug Regulatory Support
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Marketing Authorization of Pharmaceutical
Products with Special Reference to Multisource
(Generic) Products
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A Manual for a Drug Regulatory Authority
Prevention of counterfeit drugs
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guideline published
raising awareness
information sharing
cooperation between DRAs and other authorities needed
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Drug Safety
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WHO Programme for International Drug Monitoring
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more than 70 countries participating countries (2002)
Annual meetings of National Centres
Database of 3 million case reports
Free access to database by participating countries
Data mining process included
Exchange of Information
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WHO Drug Information
WHO Pharmaceutical Newsletter
WHO Drug Alerts
WHO Restricted List
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Meeting with FDA, Mar. 2002
Drug Safety
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Promoting pharamcovigilance
---Series of technical guidelines
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Safety Monitoring- Guidelines for setting up a
Pharmacovigilance Centre
The Importance of Pharmacovigilance
Guidelines for Safety monitoring in Communities
Guidelines to improve reporting by physicians
Guidelines on Crisis Management
Guidelines on Monitoring herbal medicines
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Meeting with FDA, Mar. 2002
Drug Safety
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Technical support to countries
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Partnerships and cooperations with other
organizations
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Support to the WHO Programme for International Drug
Monitoring
Regional training courses in Pharmacovigilance
Strengthen spontaneous reporting systems
Establish active surveillance programmes
Collaborating centers
CIOMS VI Working Group
Collaboration with PIC/S, EDQM, USP
Working with IPC partners - UNICEF, UNAIDS, UNFPA; WB
Working with the Pharmaceutical Industry
Working with Consumers
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Meeting with FDA, Mar. 2002
Guidance for control and use of psychotropics
and narcotics
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Undertake medical and scientific review of
psychotropic and narcotic substances before the
UN Commission on Narcotic Drugs makes
decisions
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under 1961 Single Convention on Narcotic Drugs and 1971
Convention on Psychotropic Substances
through Expert Committee on Drug Dependence
Model Guidelines for the International Provision of
Controlled Medicines for Emergency Medical Care
(1996)
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- access to narcotic pain killers remains a big problem
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Meeting with FDA, Mar. 2002
Nomenclatures, classifications
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International Nonproprietary Names (INNs)
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Collaboration with WIPO to protect INNs against use as
trademarks
INNs for biotechnological / biological products --> need
collaboration with experts
Anatomical Therapeutic Chemical (ATC)
classification and Defined Daily Dose (DDD)
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WHO Collaborating Centre for Drug Statistics and Methodology
Used by countries to measure drug consumption data
 to follow trends in drug utilization
 to audit use against guidelines
 to use in pharmacovigilance studies
 to assess the access to drugs
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Meeting with FDA, Mar. 2002
QSM’s other activities
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HIV / AIDS, TB and Antimalarial Drugs Prequalification
Expected outcomes are:
 Operational Quality Manual for Procurement of
Pharmaceuticals
 Pre-qualification of suppliers and individual AIDS-related
pharmaceutical products
 Model Quality Assurance System for Procurement of
Pharmaceuticals
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Meeting with FDA, Mar. 2002
Future Challenges
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Normative work not “sexy” for donors
WHO alone can not change the World 
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more than ever good cooperation rather than duplication and
competition needed
Dreams - Global Alliance for Quality of
Pharmaceuticals?
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Participants may include: UN organizations, DRAs,
pharmacopoeias, development institutions, international
professional societies, and NGOs
Coordinate the efforts of the participants in the field of quality
assurance of pharmaceuticals
Offer, where feasible, through joint or coordinated efforts,
technical expertise, training and/or financial support to
countries
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Meeting with FDA, Mar. 2002