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Prequalification of HIV/AIDS Drugs - UN joint activity

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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  1. 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.

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. General procedure: Pre-qualification • What will be required (2)? • 4. Finished product • 4.1. Formulation • 4.2. Sites of manufacture • 4.4. Manufacturing procedure • 4.5 Specifications for excipients • 4.6 Specifications for the finished product • 4.7 Container/closure system(s) and other packaging • 4.8 Stability testing

  7. General procedure: Pre-qualification • What will be required (3)? • 4.9 Container labelling • 4.10 Product information • 4.11 Patient information and package inserts • 4.12 Justification for any differences to the product in the country or countries issuing the submitted WHO-type certificate(s) • 4.13 Interchangeability (bio-equivalence studies) • 4.14 Summary of pharmacology, toxicology and efficacy of the product

  8. 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

  9. 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

  10. 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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