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Prequalification of HIV/AIDS Drugs - UN joint activity PowerPoint PPT Presentation


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Prequalification of HIV/AIDS Drugs - UN joint activity. Partners* UNAIDS UNICEF UNFPA WHO With the support of World Bank WHO Manages, provides technical support/assistance based on WHO norms and standards, plus ICH and other standards, where applicable. PQ team independent. .

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Prequalification of HIV/AIDS Drugs - UN joint activity

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Prequalification of HIV/AIDS Drugs - UN joint activity

  • Partners*

    • UNAIDS

    • UNICEF

    • UNFPA

    • WHO

    • With the support of World Bank

  • WHO

    • Manages, provides technical support/assistance based onWHO norms and standards, plus ICH and other standards, where applicable. PQ team independent.


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Prequalification basic principles

  • Voluntary for participating manufacturers

  • Legitimate - General procedure and standards approved through WHO Expert Committee system

  • Widely discussedin many fora

    • FIP Congress, Nice 2002

    • Supported by ICDRA in 2002 and 2004, representing more than 100 national drug regulatory authorities

    • WHA resolution 57.14 (May 2004)

  • Transparent(information on the web site http://www.who.int/medicines/)

  • Open to both innovators and multisource/generic manufacturers

  • No cost for applicants so far


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General procedure: Pre-qualification

Steps of the Procedure

  • 1. Invitation for EOI (public, drug lists)

  • 2. Guidelines for product dossier compilation

  • 3. Receiving submissions (dossiers)

  • 4. Screening of dossiers

  • 5. Dossier evaluation (WHO Manual+guidelines)

  • 6. Site inspection (GMP, GCP, GLP)

  • 7. Reports and outcome (compliance/add info?)

  • 8. Pre-qualification results (web)

  • 9. Testing of samples

    Re-qualification (3 years)


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EOI HIV and related diseases

  • NNRTIs

  • NRTIs

  • PIs

  • Anti-infectives (antibacterial, antimycobacterial, antiprotozoal, antiviral, antifungal)

  • Anticancer

  • FDCs (Lam/Stav, Lam/Zid, Lam/Stav/Efavir, Lam/Stav/Nevir, Lam/Zid/Efavir, Lam/Zid/Nevir)


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General procedure: Pre-qualification

  • What will be required (1) ?

    • 1. Details of the product

    • 2.Regulatory situation in other countries

    • 3. Active pharmaceutical ingredient (s) (API)

    • 3.1 Properties of the API

    • 3.2 Sites of manufacture

    • 3.3 Route(s) of synthesis

    • 3.4 Specifications (API described/not described in a pharmacopoeia)

    • 3.5 Stability testing

      • WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-fourth report. Geneva, World Health Organization, 1996: 65-79(WHO TRS, No 863) http://www.ifpma.org/ich5q.html#stability


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General procedure: Pre-qualification

  • What will be required (2)?

    • 4. Finished product

    • 4.1.Formulation

    • 4.2. Sites of manufacture

    • 4.4. Manufacturing procedure

    • 4.5Specifications for excipients

    • 4.6Specifications for the finished product

    • 4.7Container/closure system(s) and other packaging

    • 4.8Stability testing


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General procedure: Pre-qualification

  • What will be required (3)?

    • 4.9Container labelling

    • 4.10Product information

    • 4.11Patient information and package inserts

    • 4.12Justification for any differences to the product in the country or countries issuing the submitted WHO-type certificate(s)

    • 4.13Interchangeability (bio-equivalence studies)

    • 4.14Summary of pharmacology, toxicology and efficacy of the product


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Access to HIV/AIDS Drugs of Acceptable Quality

  • What are the technical difficulties and problems experienced or revealed as a result of pre-qualification?

  • Quality of product dossiers varied

    • Lack of information regarding API, validation, specifications, bio-equivalence

    • DRAs not applying same standards as recommended by WHO, yet products are registered and used

    • Very few substances and products have Pharmacopoeia monographs

    • What standards to apply? If standards not available - full assessment necessary


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Access to HIV/AIDS Drugs of Acceptable Quality

  • Difficulties and problems (cont)

    Manufacturing site inspections

    • Manufacturers not ready

    • Upgrading of facilities to comply with WHO GMP

    • DRAs issued CPP – yet non-compliance

    • Inspections reveal non-compliance, e.g. antibiotics (penicillin), hormones and other products manufactured in the same site

    • No validation


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The prequalification part of the project has two major activities: countries are providing expertise

  • I. Assessment of products dossiers i.e. quality specifications, pharmaceutical development, bioequivalence etc. : Brazil, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Indonesia, Malaysia, Philippines, Spain, South-Africa, Sweden, Switzerland, Tanzania, Zimbabwe ...

  • II. Manufacturing site inspections: teamwork of inspectors: WHO representative (qualified GMP inspector), inspector from well-established inspectorate (Pharmaceutical Inspection Convention Scheme countries) and national inspector(s): Canada, France, Italy, Switzerland, The Netherlands …

  • Quality control analysis - upon need but not always necessarily before prequalification and supply, increasingly as part of follow-up


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