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PREQUALIFICATION General overview and procedures

PREQUALIFICATION General overview and procedures for the procurement agencies involved in procurement. Procurement and Supply Management for HIV/AIDS, TB and Malaria Workshop 13-16 March 2006, Moscow, RF. Alexander Polishchuk

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PREQUALIFICATION General overview and procedures

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  1. PREQUALIFICATION General overview and procedures for the procurement agencies involved in procurement Procurement and Supply Management for HIV/AIDS, TB and Malaria Workshop 13-16 March 2006, Moscow, RF Alexander Polishchuk Special Project on Pharmaceutical for NIS, Health Technologies and Pharmaceuticals World Health Organization Regional Office for Europe E-mail: apo@euro.who.int

  2. Prequalification of essential medicines • The UN prequalification program is an action plan for expanding access for the hardest hit by • HIV/AIDS • Tuberculosis • Malaria • for ensuring quality, efficacy and safety of medicines all the way through the medicines supply chain.

  3. Why the prequalification is needed • Problems • Millions of people living with HIV/AIDS, tuberculosis and malaria, have no or limited access to treatment • Procurement and supply of substandard and counterfeit products in different countries • Weak/absent QA systems of medicines supply chain • Lot of money invested in procurement no harmonized quality assurance system available for procurement organizations • Risks • Sourcing of poor quality products or even counterfeit medicines risk to patients, treatment failure, resistance

  4. Incorrect ingredient 16% Incorrect amount 17% No active ingredient Other errors 60% 7% Is quality of pharmaceuticals a problem? Substandard drugs is a big problem - antibiotics, antimalarials, antituberculosis, antiretrovirals drugs included Percentage breakdown of data on 325 cases of substandard drugs - reported from around the world to WHO database

  5. Expected outcome of prequalification • List of products and manufacturers/CROs • Meeting international norms and standards on quality, safety, and efficacy (Q, S & E) • Harmonization • Co-operation, training, capacity building – NDRAs, WHO, NGOs • Facilitate access to treatment • Procurement mechanisms (e.g. tender, competition) • Ongoing monitoring of Quality, Safety & Efficacy • WHO commitment to developing

  6. Steps of prequalification 1. Expression of interest (EOI) from a prospective supplier interested in a voluntary participation in the program. 2. Receipt of the dossier at UNICEF in Copenhagen and the Site Master File in WHO Geneva. • Explicative notes and guidelines are published on the WEB in order to explain how to bring together a product dossier meeting the requirements for prequalification. 3. Screeningof the dossier, "Quality" part, "Clinical" part and samples.  possible inspection 4. Assessment of the dossier and writing of the assessment report and assessment letter. 5. Outcome of the evaluation communicated to supplier

  7. Steps of prequalificationcont… 6.Inspection of the site (s) of manufacturing and follow-up inspection when necessary  GMP compliant list of manufacturers 7.Inspection of the Research Laboratory or Contract Research Laboratory (CRO)where the bioequivalence study has been performed GCP compliant list of CROs 8.Conclusion and listingof the product in the prequalification list 9.Publication of the Public Assessment (WHOPAR) and Inspection (WHOPIR) Reports 10.Assessment of the variation when submitted, market survey, de-listing if necessary 11.Re-qualification after 3 years

  8. Assessment procedure • Assessment of products dossiersi.e. quality, specifications, pharmaceutical development, bioequivalence etc. • teams of professionals from national drug regulatory authorities (DRA):Brazil, Canada, Denmark, Estonia, Finland, France, Germany, Hungary, Indonesia, Malaysia, Philippines, Spain, South-Africa, Sweden, Switzerland, Tanzania, Zimbabwe ... • Copenhagen assessment week • 8 to 12 assessors together during one week at least every two months at UNICEF in Copenhagen • Every dossier is assessed by at least two assessors. • An assessment report is issued; signed by two assessors • Letter summarizing the findings and asking for clarification and additional data if necessary. • Letter is sent first by e-mail to the applicant followed by surface mail

  9. Assessment procedure-Product dossiers • Innovator products • Assessment report from DRAs • WHO type Certificate of Pharmaceutical Product (CPP) • Batch certificate • Update on changes. • Multisource products (generics) • Full dossier with data and information • Quality : information on starting materials and finished product including API details, specifications, stability data, formulation, manufacturing method, packaging, labelling etc • Efficacy: Bio-equivalence study or clinical study report • US FDA tentative approvals – recognition based on information exchange (Confidentiality agreement) • Commercial sample

  10. Inspection procedure Inspections • Manufacturing site (FPP, packaging) • Active pharmaceutical ingredient(API) • Research laboratory/Contract Research Organization (CRO) • Teamwork of inspectors • WHO representative (qualified GMP inspector) • Inspector from well-established inspectorate (Pharmaceutical Inspection Convention Scheme PIC/S countries) • National inspector(s): Canada, India, China, France, Italy, Switzerland, South-Africa, Thailand… Quality control analysis - upon need but not always necessarily before prequalification and supply; increasingly as part of follow-up

  11. Current status – December 2005 • Started with HIV/AIDS products in 2001 – malaria and TB products joined later • Prequalified products (Dec 2005) Dossiers arrived • 105 HIV related medicines - 316 (Aug-05) 343 (Dec -05) • 8 anti-tuberculosis medicines - 156 165 • 2 anti-malarial medicines - 48 49 • 115 520 557 • Ongoing assessments and follow-up • Products • Manufacturing sites • CROs

  12. Current status – Manufacturers of finished products • In the prequalification list: 15 sites of generics • Asia: 9 sites • Europe: 4 sites • Africa: 2 sites

  13. Ongoing monitoring and requalification • Samples taken after supply • Routine inspections and additional inspections • Changes and variations controlled • Products and manufacturers • Requalification (re-assessment) every 3 years • World Health Assembly resolution: WHA57.14 of May 2004 Public reports requested • WHOPIRs (WHO Public inspection report) and WHOPARs (WHO Public Assessment Report) are now on the prequalification web site • Increasing interest in WHO Public Inspection Reports (WHOPIR)

  14. PQ web site information for procurement • List of prequalified products • List of manufacturers of manufacturers for APIs (Active Pharmaceutical Ingredient) and FFPs (Finished Pharmaceutical Product), which are GMP compliant • List of GCP compliant Contract Research Organisations (CROs), bio-equivalence centers and research laboratories, which are GCP/GLP compliant • WHOPIRs (WHO Public Inspection Report) • WHOPARs (WHO Public Assessment Report)

  15. Important in the PQ process related to Quality and Efficacy • Dossier evaluation and Inspections (GMP = manufacturing and GCP for bioequivalence studies) Go hand in hand in the PQ process Sometimes "GMP compliance" alone does not tell the whole truth!! Dossier assessment Inspections GMP/GCP

  16. This is misleading and/or misunderstood • WHO type certificate (by WHO Certification Scheme) is used worldwide  But it is notWHO certificate • GMP compliance?? • National GMP requirements are not always those of WHO or stringent authority requirements • Does not tell everything about the product

  17. !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!This is correct!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! • WHO Prequalification does not give GMP/GCP certificates, but the GMP/GCP compliant companies are listed in our web site WHO GMP/GCP CERTIFICATE

  18. Summary and conclusion • Good news; quality of generics exists • Relatively large number of products and suppliers comply with the standards • Many potential suppliers appreciating feedback and willing to improve • Unique technical knowledge obtained of products, especially generic antiretrovirals and antimalarials • Bad news: quality assurance has the price • Only limited number of products have met the required standards • Takes time to get into compliance • Data to be generated, tests carried out • GMP upgrade needed • Bad quality generics may undermine the public confidence in generics

  19. Summary and conclusion CONT… However… REMEMBER Quality can not be assessed, tested or inspected into the product, BUT has to bebuilt into the product in all the steps … development phase, production, QC, BE study etc. with the help of guidelines, regulatory requirements etc.!! More technical help to manufacturers in developing countries is needed!!

  20. http://mednet3.who.int/prequal/

  21. Что делать в этой ситуации?

  22. THANK YOU VERY MUCH FOR YOUR ATTENTION!!

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