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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: ragol@who.ch.

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slide1

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: ragol@who.ch

why normative work is needed
Why normative work is needed?
  • Medicines are very specific category of products
    • Patients/consumers limited capacity to assess their safety, efficacy and quality
    • Pharmacists and medical doctors - the same
  • Medicines must meet three basic criteria
    • SAFETY
    • EFFECACY
    • QUALITY
to assess quality safety and efficacy norms and standards are needed
To assess QUALITY, SAFETY and EFFICACY norms and standards are needed
  • New innovative medicines (NCE or NDA)
    • QUALITY, SAFETY; EFFICACY
  • Multisource or generic medicine
    • QUALITY, and proof of being therapeutically interchangeable
slide4

WHO medicines strategy

Normative work on pharmaceuticals - Health Technology and Pharmaceuticals Cluster

  • Essential Drugs and Medicines Policy
    • 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
slide5

Quality Assurance and Safety: Medicines Team (QSM) --- areas of work

  • Norms, standards and guidelines for quality, safety and efficacy of pharmaceuticals
    • International Pharmacopoeia, GMP, GCP etc.
  • Nomenclatures, classifications
    • 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
    • The WHO Programme for International Drug Monitoring etc.
  • Drug regulatory support
    • WHO Certification Scheme, assessment of NDRAs, training for regulators etc.
slide6

Norms and standards for pharmaceuticals

  • International Pharmacopoeia
    • 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
  • Basic tests
    • 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
slide7

Guidelines for pharmaceuticals

  • Good Manufacturing Practices (GMP)
    • 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
  • Inspection of manufactures and distribution channels
  • Good Storage Practices
    • Adopted at the Expert Committee
slide8

Guidelines for pharmaceuticals

  • 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

slide9

Drug Regulatory Support

  • WHO Certification Scheme
    • on the quality of pharmaceutical products
    • on the quality of starting materials
  • Assessment of NDRAs --> “evidence based” interventions and training for regulators
  • WHO Basic Training Modules on GMP
    • Training workshop for inspectors
  • Medical Products and the Internet: A Guide to Finding Reliable Information
    • Guide to consumers
  • Model web site for drug regulatory authorities
slide10

Drug Regulatory Support

  • International Conference of Drug Regulatory Authorities (ICDRA)
    • promoting collaboration and exchange of information between DRAs
    • discussing common regulatory challenges
  • Promotion of regulatory harmonization
    • acting as a link between ICH and non-ICH countries
    • regional harmonization (PAHO, ASEAN etc.)
  • SIAMED (computer-assisted drug registration system)
    • jointly developed with PAHO
slide11

Drug Regulatory Support

  • Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products
    • A Manual for a Drug Regulatory Authority
  • Prevention of counterfeit drugs
    • guideline published
    • raising awareness
    • information sharing
    • cooperation between DRAs and other authorities needed
slide12

Drug Safety

  • WHO Programme for International Drug Monitoring
    • 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
    • WHO Drug Information
    • WHO Pharmaceutical Newsletter
    • WHO Drug Alerts
    • WHO Restricted List
slide13

Drug Safety

  • Promoting pharamcovigilance

---Series of technical guidelines

    • 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
slide14

Drug Safety

  • Technical support to countries
    • Support to the WHO Programme for International Drug Monitoring
    • Regional training courses in Pharmacovigilance
    • Strengthen spontaneous reporting systems
    • Establish active surveillance programmes
  • Partnerships and cooperations with other organizations
    • 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
slide15

Guidance for control and use of psychotropics and narcotics

  • Undertake medical and scientific review of psychotropic and narcotic substances before the UN Commission on Narcotic Drugs makes decisions
    • 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)
    • - access to narcotic pain killers remains a big problem
slide16

Nomenclatures, classifications

  • International Nonproprietary Names (INNs)
    • 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)
    • 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
slide17

QSM’s other activities

  • HIV / AIDS, TB and Antimalarial Drugs Pre-qualification

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
slide18

Future Challenges

  • Normative work not “sexy” for donors
  • WHO alone can not change the World -
    • more than ever good cooperation rather than duplication and competition needed
  • Dreams - Global Alliance for Quality of Pharmaceuticals?
    • 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