WHO Essential Drugs Strategy

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Safe quality medicines
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Medicines quality assurance WHO's normative
functions in the field of pharmaceuticals

Sabine Kopp, PhD Quality Assurance and Safety
Medicines Department of Essential Medicines and
Health Products
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Main points addressed

• Who is WHO?
• How does WHO set standards?
• Which WHO guidelines, standards and norms exist
  in the area of quality assurance?
• What's new ?

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Who is WHO? Governing bodies

• World Health Assembly (WHA)
• Delegations from 194 Member States
• Meeting yearly in May
• Executive Board (EB)
• Representatives from 34 Member States
• Meeting biannually in January and May

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Impressions from World Health Assembly

• - SSFFC

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WHO is WHO ? Secretariat and Experts

• WHO Secretariat
• - Headquarters
• - six Regional Offices and 149 Country
  offices
• Experts
• - WHO Expert Panels and Expert
  Committees
• - WHO Collaborating Centres
• - partners
• Constitution signed 1946, in force since 7 April
  1948 (World Health Day)

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WHO Governing bodies

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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

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WHO Expert Committees rules and procedures ? WHO
Basic Documents

• Constitution of WHO
• Expert Committees
• chapter V, article 18 chapter VIII, articles
  38-40
• For normative function - pharmaceuticals
• Chapter 2, article 2 (u) " to develop,
  establish and promote international standards
  with respect to food, biological, pharmaceutical
  and similar products"
• Regulations for Expert Advisory Panels and
  Committees, including, Annex Rules of Procedure
  for Expert Committees

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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
• .

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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

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When does the WHO Expert Committee start
development of a guideline/guidance?

• Based on recommendations by
• World Health Assembly resolutions (e.g. WHA
  20.34, GMP - Good manufacturing practices)
• Executive Board resolutions (e.g. EB37.R9
  delegating certain functions of INN Programme to
  DG based on advice from Experts)
• International Conference of Drug Regulatory
  Authorities (e.g. 10th 11th ICDRA FDC
  guidelines Certification Scheme for
  pharmaceutical starting materials moving into
  international commerce)
• Other WHO programmes and clusters (e.g. necessity
  for quality control specifications for specific
  medicines of major public health interest and
  feedback from Prequlifcation programme)
• Expert Committee (e.g. revision of general
  methods included in The International
  Pharmacopoeia)

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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

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WHO Partners

• With Regulatory Bodies
• National/Regional regulatory authorities
• Regional/Interregional regulatory groups (ASEAN,
  GCC, ICH, PANDRH...)
• Within WHO
• WHO disease programmes (Stop TB, Roll-Back
  Malaria, HIV/AIDS, Tropical Neglected Diseases,
  programmes on Children, Women's Health )
• Prequalification Programme A United Nations
  Programme managed by WHO

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WHO Partners (2)

• With Organizations and Associations
• International organizations (UNAIDS, UNICEF,
  IAEA, Global Fund, World Bank)
• International professional and other
  associations, NGOs (incl. industry, consumer
  associations IFPMA, IGPA, WSMI, IPEC, FIP, WMA,
  MSF)
• With Standard-setting Bodies, such as
• Pharmacopoeia Commissions and Secretariats (e.g.
  British Brazilian, Chinese, European, Indian,
  Korean, Japanese, USP, .. )

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WHO Partners (3)

• With "recognized" Experts
• WHO Expert Panel on The International
  Pharmacopoeia and Pharmaceutical Preparations
  (official nomination process)
• Specialists from all areas for specific projects
  (regulatory, university, industry)
• With "recognized" Laboratories
• National/Regional Quality control laboratories
• WHO Collaborating Centres (official nomination
  process)

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Medicines Quality Assurance in WHO Historical
overview

• 1st "WHO Expert Committee on Specifications for
  Pharmaceutical Preparations" ( ECSPP) meeting
  held 13-17 October 1947
• Report of 1st ECSPP meeting published in
• Official Records of WHO, No 8, page 54ff, 1947

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WHOs medicines quality assurance guidelines

• Cover
• Development
• Production
• Quality Control
• Quality related regulatory guidelines
• Inspection
• Distribution
• ? from manufacture (and before) to delivery to
  patient

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Adopted WHO guidance texts and guidelinesin
medicines quality assurance (without PhInt)

• Maintain to keep up to date
• More than 60 CURRENT official WHO guidance texts
  and guidelines to date
• 8 updates 7 new adopted 2010
• 2 updates 4 new adopted 2011
• 2 updates 2 new adopted 2012.

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Quality Control

• http//www.who.int/medicines/areas/quality_safety/
  quality_assurance/control/
• More than 10 guidance documents and guidelines,
  including
• Good laboratory practices training materials
• Guidelines for establishment of chemical
  reference standards
• Model certificate of analysis
• International Pharmacopoeia Basic tests

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International PharmacopoeiaPh.Int.

• current 4th edition! Supplement 1 2
• 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, medicines
  for children

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Distribution

• http//www.who.int/medicines/areas/quality_safety/
  quality_assurance/distribution
• Some 10 guidance documents and guidelines, e.g.
• Certification schemes (CPP and SMACS)
• Quality system for Procurement
• Good distribution practices for starting
  materials and finished products
• Good storage practices

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Production

• http//www.who.int/medicines/areas/quality_safety/
  quality_assurance/production/
• Some 20 guidance documents and guidelines,
  including
• Good Manufacturing Practices (GMP)
• ..Consisting of more than 10 major "guideline"
  texts (regularly updated, new texts added as
  needs are identified)
• .. Training materials (slides, video, GMP text)
• Risk analysis (HACCP) moving to "quality risk
  management"

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Quality related regulatory standards

• http//www.who.int/medicines/areas/quality_safety/
  quality_assurance/regulatory_standards/
• Some 20 guidance documents and guidelines,
  including
• Stability testing requirements
• Interchangeability of generic medicines
• Fixed-dose combination
• All prequalification procedures

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47th WHO Expert Committee on Specifications for
Pharmaceutical Preparations outcome - 1-

• 1. Adopted texts The International Pharmacopoeia
• Monographs for the following
• - Medicines for HIV and related conditions
• - Antimalarial medicines
• - Antituberculosis medicines
• - Anti-infectives
• Harmonized general texts (based on PDG texts)

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47th WHO Expert Committee on Specifications for
Pharmaceutical Preparations outcome -2-

• 2. Adopted global quality assurance guidelines
• New guidance on quality risk management (QRM)
• Guidance on variations to a prequalified product
  (revision)
• Collaborative procedure between WHO PQ and NMRAs
  in the assessment and accelerated registration of
  national WHO-prequalified pharmaceutical products

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46th WHO Expert Committee on Specifications for
Pharmaceutical Preparations outcome -3-

• Quality requirements of artemisinin as a starting
  material in the production of antimalarial active
  pharmaceutical ingredients

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Advantages of WHO's Expert Committee
standard-setting process

• 1. Guidelines and specifications validated
  internationally, through an independent
  scientific process, adoption by members of WHO
  Expert Advisory Panels
• 2. Collaboration with standard-setting
  organizations and parties, including regional and
  national pharmacopoeias
• 3. Networking and close collaboration with WHO
  Member States, Drug Regulatory Authorities,
  national medicines quality control laboratories

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Advantages of WHO's Expert Committee
standard-setting process (2)

• 4. Links with other WHO activities
• 5. Reality check Input from manufacturers
  (including international associations of
  research, generic and self-medication
  associations) around the world
• 6. Consideration of costs, e.g. keeping need for
  reference standards at a minimum
• 7. Service FREE FOR USE by all Member States

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WHO Medicines Quality Assurance
websitehttp//www.who.int/medicines/areas/quali
ty_safety/quality_assurance
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Safe quality medicines