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WHO Essential Drugs Strategy


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

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

Sabine Kopp, PhD Quality Assurance and Safety
Medicines Department of Medicines Policy and
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

WHO does the work?
  • 193 Member States
  • Two governing bodies - World Health
    - 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)

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
  • WHO Headquarters
  • Period of maximum 4 years
  • Possibility to renew

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

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

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
  • Joint FAO/WHO Expert Committee on Food Additives
  • .

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
  • ? WHO Expert Committee (EC) meeting
  • ? if guideline adopted, published in EC report as
  • -gt WHO Governing bodies
  • -gt Recommendation to Member States for

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
  • Pharmacopoeia Commissions and Secretariats,
    national institutions and institutes ..
  • Regional and inter-regional groups (ICH)

Quality Assurance in WHO Historical overview
  • 1874 Discussion on Unification of terminology and
    composition of drugs
  • 1902 First Conference organized by Belgian
  • 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

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

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

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

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
  • Cross-border promotion and sale
  • Free trade zones

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

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

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

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

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

WHOs global guidelines - quality control -
  • International specifications (Int.Ph., screening
  • 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

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

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

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

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)

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

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)
  • Validation
  • 3. for specific pharmaceutical products
  • Herbal medicines (revised)

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

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

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

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

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

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

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
  • ....

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

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
  • 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)


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

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!
WHO Medicines Quality Assurance
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