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

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. Main points addressed. WHO role and function WHO standard setting process

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

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  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 • -> WHO Governing bodies • -> 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: “international 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 -> 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. WHO’s 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. WHO’s 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. WHO’s strategy for quality control • Step-wise approach: • - Basic tests (identification) • - Screening tests (TLC) • - The International Pharmacopoeia • - International chemical reference standards (ICRS) • - IR reference spectra

  21. WHO’s 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

  22. 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

  23. 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

  24. Participation in External Quality Assurance Scheme -> 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

  25. WHO’s 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)

  26. WHO’s 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

  27. WHO’s 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)

  28. WHO’s 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

  29. WHO’s global guidelines and strategies - risk analysis • Application of risk analysis to production of pharmaceuticals (adopted in 2001)

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

  31. 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

  32. 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 -> preference to provide "real" conditions required by national authorities

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

  34. Related WHO’s 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 • ....

  35. WHO’s 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)

  36. WHO’s 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)

  37. 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

  38. 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!

  39. WHO Medicines Quality Assurance website:http://www.who.int/medicines/areas/quality_safety/quality_assurance

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