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WHO Essential Drugs Strategy

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How to become a 'WHO Expert'? Official nomination process ... Requirements for drug registration and model legislation ... Model List of Essential Medicines and ... – PowerPoint PPT presentation

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Title: WHO Essential Drugs Strategy


1
Drug regulation and quality assurance WHO
normative functions in the field of
pharmaceuticals

Sabine Kopp, PhD Quality Assurance and Safety
Medicines Department of Medicines Policy and
Standards
2
Main points addressed
  • WHO role and function
  • WHO standard setting process
  • WHO international guidelines, standards and norms
    in the area of quality assurance
  • WHO's operational strategies

3
WHO does the work?
  • 193 Member States
  • Two governing bodies - World Health
    Assembly
    - Executive Board
  • WHO Secretariat - HQ - six
    Regional Offices - WHO Expert Panels
    (e.g... on the International Pharmacopoeia
    and Pharmaceutical Preparations)
    Constitution 1946, in force since 7 April
    1948 (World Health Day)

4
How to become a "WHO Expert"?
  • Official nomination process
  • Upon proposal to WHO in consultation with
  • Member State/national government (citizenship)
  • WHO Regional Office (in accordance with Member
    State)
  • WHO Headquarters
  • Period of maximum 4 years
  • Possibility to renew

5
What is the WHO Expert Committee?
  • Official Advisory Body to Director-General of WHO
  • Governed though rules and procedures (Ref. WHO
    Manual)
  • Participation in Expert Committee (EC) meetings
  • Members ("Expert") selected from WHO Panel of
    Experts
  • Technical advisers
  • Observers - international organizations,
    - NGOs, - professional
    associations

6
Outcome of the WHO Expert Committee?
  • Report of the WHO Expert Committee
  • Summarizes discussion
  • Gives recommendations to WHO Member States
  • Includes newly adopted guidelines
  • Is presented to WHO Governing Bodies for final
    comments, endorsement and implementation by
    Member States
  • ? constitutes WHO technical guidance

7
Examples of WHO Expert Committees ?
  • WHO Expert Committee on Specifications for
    Pharmaceutical Preparations
  • WHO Expert Committee on the Selection and Use of
    Essential Medicines
  • WHO Expert Committee on Drug Dependence
  • WHO Expert Committee on Biological
    Standardization
  • Joint FAO/WHO Expert Committee on Food Additives
  • .

8
How does the WHO consultation process work?
  • Step 1. Preliminary consultation and drafting
  • Step 2. Draft guidelines
  • Step 3. Circulation for comments
  • Step 4. Revision process
  • .......... (back to step 2 and 3 as often as
    needed)
  • ? WHO Expert Committee (EC) meeting
  • ? if guideline adopted, published in EC report as
    Annex
  • -gt WHO Governing bodies
  • -gt Recommendation to Member States for
    implementation

9
WHO Partners
  • National and regional authorities
  • International organizations (UNAIDS, UNFPA,
    UNICEF, World Bank, WIPO, WTO, WCO, etc)
  • International professional and other
    associations, NGOs (including consumer
    associations, MSF, industry IFPMA-IGPA- WSMI,
    FIP, WMA, etc)
  • WHO Expert Panels (official nomination process)
  • Specialists from all areas, regulatory,
    university, industry
  • WHO Collaborating Centres (official nomination
    process)
  • Pharmacopoeia Commissions and Secretariats,
    national institutions and institutes ..
  • Regional and inter-regional groups (ICH)

10
Quality Assurance in WHO Historical overview
  • 1874 Discussion on Unification of terminology and
    composition of drugs
  • 1902 First Conference organized by Belgian
    Government
  • 1906 Agreement on Unification of the Formulae of
    Potent Drugs ratified by 19 states
  • 1925 Brussels agreement (signed 1929)
  • League of Nations internati
    onal pharmacopoeia

11
Quality Assurance in WHO Historical overview
- 2 -
  • 1937 First meeting (experts from B, DK, F, NL,
    CH, UK, USA) - League of Nations
  • 1947 Interim Commission of WHO takes up health
    related work of League of Nations
  • 1948 First World Health Assembly established
    Expert Committee on Unification of Pharmacopoeia

12
Challenges past and present
  • Past
  • Manufacture direct from API -gt finished product
  • Manufacture of API in sites close to or same as
    product
  • Experience and long-standing knowledge of
    production, product and manufacture of parties
    involved
  • Few intermediates in sales chain
  • Usually stable trade and sales connections

13
Challenges past and present
  • Present
  • Rationalization of drug production
  • Contracting-out of many steps in manufacture
  • Many intermediates in trade and sales chain
  • Trade, shipping, long distances involved
  • Increase of risks
  • Increase of requirements and documentation
  • Increase of national control mechanisms

14
Global challenges
  • National vs international requirements
  • Number of requirements
  • Application and interpretation of requirements
  • Import vs export control on national level
  • Quality assurance systems applied
  • Knowledge of product by parties involved in
    manufacture
  • Cross-border promotion and sale
  • Free trade zones

15
Global challenges
  • Number of national and international inspections
    by same party
  • Number of inspections in same site by different
    parties
  • Applicability of new technologies in different
    settings
  • Contracts, agreements, eg Mutual Recognition
    Agreements
  • Risks of mistakes, accidents, human errors etc
  • Counterfeit drugs
  • ...

16
WHOs global guidelines and strategies
  • Requirements for drug registration and model
    legislation
  • Networking among and with regulatory authorities
  • International alerts
  • Counterfeit network
  • Global norms and standards and nomenclature (INN)
    ..

17
INNs
18
WHOs global quality assurance guidelines
  • Cover
  • Production
  • Quality Control
  • Quality related regulatory guidelines
  • Inspection
  • Distribution
  • ? from manufacture to delivery to patient

19
International Pharmacopoeia
  • current 4th edition! Supplement 1 in preparation
  • implementation ready for use by Member States
  • Scope since 1975
  • Model List of Essential Medicines and
  • Drugs recommended by WHO Specific disease
    programmes, e.g. Malaria, TB, HIV/AIDS

20
(No Transcript)
21
WHOs strategy for quality control
  • Step-wise approach
  • - Basic tests (identification)
  • - Screening tests (TLC)
  • - The International Pharmacopoeia
  • - International chemical reference standards
    (ICRS)
  • - IR reference spectra

22
WHOs global guidelines - quality control -
  • International specifications (Int.Ph., screening
    tests..)
  • WHO Model Certificate of Analysis (COA)
  • Considerations for requesting analysis of samples
  • Quality control laboratories
  • Good practices for national control labs
  • List of equipment
  • External qc assessment scheme for labs

23
External Quality Assessment Scheme for National
Drug Quality Control Laboratories
  • Capacity building
  • Third phase
  • Series of 5 tests
  • 42 participating laboratories, including WHO
    Collaborating Centres
  • In all 6 WHO regions

24
External Quality Assessment Scheme for National
Drug Quality Control Laboratories
  • Phase 4 (06/2007 - 01/2009)
  • - 50 laboratories invited to participate.
  • - Studies
  • Titration
  • Water content by Karl-Fisher
  • Dissolution test
  • Determination of glucose by polarimetry
  • HPLC assay

25
Participation in External Quality Assurance
Scheme -gt link with PQ Programme
  • Phase 3 (07/2004 - 06/2006)
  • 11 of QC laboratories involved in
    prequalification procedure participated
  • Algeria, South Africa CENQAM, South Africa RIIP
  • Ghana, Kenya, Mali, Niger, Senegal, Tanzania,
    Uganda, Zimbabwe
  • 2 other African QC laboratories took part
  • Morocco, Tunisia
  • Phase 4 (06/2007 - 01/2009)
  • All 15 QC laboratories involved in
    prequalification procedure invited

26
WHOs global guidelines - distribution
  • WHO Certification Scheme for Products Moving in
    International Commerce
  • SMACS new scheme for pharmaceutical starting
    materials - model certificate, when inspected
    by national authority
  • - WHO model for self-assessment for manufacture
    of pharmaceutical starting materials
  • Good Distribution and Trading Practices for
    pharmaceutical starting materials (GTDP)
  • Good Distribution Practices (GDP) (for products)
  • Good Storage Practices (GSP)

27
WHOs global guidelines - production
  • Good Manufacturing Practices (GMP) ..
  • 1. Main principles for pharmaceutical products
  • 2. for starting materials, including
  • active pharmaceutical ingredients
  • pharmaceutical excipients
  • 3. for specific pharmaceutical products
  • Sterile pharmaceutical products
  • Biological products
  • Investigational pharmaceutical products for
    clinical trials in humans
  • Herbal medicines
  • Radiopharmaceuticals

28
WHOs global guidelines - production (2)
  • New additional GMP texts
  • 1. Main principles for pharmaceutical products
  • requirement for the sampling of starting
    materials (amendment)
  • water for pharmaceutical use
  • heating, ventilation and air-conditioning (HVAC)
    systems
  • Validation
  • 3. for specific pharmaceutical products
  • Herbal medicines (revised)

29
WHOs global guidelines - inspection
  • Inspection of..
  • pharmaceutical manufacturers
  • drug distribution channels (products)
  • Guidelines for pre-approval inspection
  • Quality systems requirements for national GMP
    inspectorates
  • Model GMP certificate
  • Model report for inspections

30
WHOs global guidelines and strategies - risk
analysis
  • Application of risk analysis to production of
    pharmaceuticals (adopted in 2001)

31
WHO stability guidelines
  • Title guidelines for stability testing of
    pharmaceutical products containing well
    established drug substances in conventional
    dosage forms currently under revision !
  • -gt stability testing of final drug products
  • -gt well established (e.g. generics)
  • -gt in conventional dosage forms (e.g. tablets)
  • --gt close collaboration with
  • ICH group Q1, ASEAN and regional harmonization
    groups

32
WHO Stability guidelines second draft What's new?
  • Scope covers
  • active pharmaceutical ingredients
    pharmaceutical products
  • Marketed new
  • Transition period recommended for already
    marketed actives and products
  • Additional advice given, e.g. model reports
    currently used in WHO Prequalification Programme

33
WHO Stability guidelines second draft What's new?
ctd -
  • Cross-reference to other guidelines, e.g. ICH
    text on photostability
  • List of WHO Member States' required long-term
    stability conditions as per info received from
    countries, concept of classification of countries
    according to climatic zones abandoned
  • -gt preference to provide "real" conditions
    required by national authorities

34
WHOs guidance on interchangeability of medicines
  • WHO guideline on registration requirements to
    established interchangeability for multisource
    pharmaceutical products (newly revised 2006)
  • Guidance on selection of comparator products for
    equivalence assessment of interchangeable generic
    products (under revision)
  • Proposal to waive in vivo bioequivalence
    requirements for the WHO model List of Essential
    Medicines (immediate release, solid dosage forms)
  • Guidelines for organizations performing in vivo
    bioequivalence studies

35
Related WHOs guidances
  • All guidelines for Prequalification of medicines,
    laboratories ..
  • Model Quality Assurance System for Assessment of
    Procurement Agencies
  • Guideline for sampling of pharmaceuticals
  • Guidelines for registration of fixed-dose
    combination medicinal products
  • ....

36
WHOs operational strategies
  • Assist Member States to strengthen or establish
    national drug regulation (upon request)
  • Study alternative ways of improving control and
    safe trade of starting materials and products
  • Promote cooperation and harmonization among
    countries (e.g. ICDRA)
  • Collaborate with regional and inter-regional
    regulatory harmonization efforts (in all 6 WHO
    regions)

37
WHOs operational strategies -2-
  • Work with interested parties and countries to
    combat counterfeit and substandard drugs (IMPACT)
  • Assistance in establishing and evaluation of
    national and regional quality control
    laboratories
  • Training of drug regulatory staff (e.g. in
    registration of HIV/AIDS medicines)
  • Development of how to manuals and tools
  • Responding to national and international requests
    in area of quality assurance for medicines (e.g.
    for Global Fund)

38

WHO efforts
  • ? aim to improve access to quality medicines
  • Provide standards and norms in area of quality
    assurance of medicines
  • Prequalification programme for UN procurement
  • Provide assistance in regulatory area
  • Promote logical order of actions
  • Priority setting (ABC first )
  • Capacity building
  • Collaboration and co-operation

39
As health professionals, in public and private
sector, as an international community ...we have
a lot left to do all of us, together, things
that do matter, in right time and in right order!
40
WHO Medicines Quality Assurance
websitehttp//www.who.int/medicines/areas/quali
ty_safety/quality_assurance
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