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Prequalification Programme of Medicines (PQP): Introductory messages

Prequalification Programme of Medicines (PQP): Introductory messages. EMP TBS, 3 November 2011 Dr Lembit Rägo. Background. 2000 - Differences in procurement QA policies mapped Started 2001 in conjunction with the UN general response to HIV/AIDS pandemic

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Prequalification Programme of Medicines (PQP): Introductory messages

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  1. Prequalification Programme of Medicines (PQP): Introductory messages EMP TBS, 3 November 2011 Dr Lembit Rägo

  2. Background • 2000 - Differences in procurement QA policies mapped • Started 2001 in conjunction with the UN general response to HIV/AIDS pandemic • Was expanded to other groups of products gradually: TB, malaria, reproductive health, influenza, Zn, diethylcarbamazine • Sub-programme for prequalification of QC labs added

  3. Principles • Transparency • Based on international standards - WHO, ICH and NRAs • Close cooperation with NRAs • Open to regulators from all countries • Capacity building since beginning important component • No duplication of efforts • Harmonization of requirements and using best practices

  4. PQ of Medicines Programme (PQP): messages • WHO’s standing in global healthcare provides the most inclusive and effective regulatory pathway for the needs of developing world • PQP is the most trusted source of quality medicines for major international funding/procurement organizations and other parties (NGOs, national procurement, regulators) • Global supply capabilities have been strengthened and expanded because of the PQP • Independent surveys show that pharmaceutical manufacturers are satisfied with and highly value PQP

  5. PQ of Medicines Programme (PQP) • PQP has been very effective “engine” for pulling the quality of Essential Medicines Agenda • Promoting quality of Essential Medicines (no poor quality medicines for poor people!) • Promoting and facilitating harmonization of quality assurance policies and strategies of funding and/or procurement mechanisms – impact at country level • Offering new effective ways of regulatory capacity building (hands-on training, doing it with the countries for countries) and harmonization (level playing field)

  6. PQP: Past and Future • PQP has come a long way since its inception but… • …the global health arena is changing fast…and… • …significant challenges remain • To be more responsive and accountable to stakeholders, PQP • Holds meetings with manufacturers and enabling partners • manages External Review Panel (ERP) process, working on risk-based approach for EM, prequalification of selected APIs • Provides technical assistance • based on the input from stakeholders PQ conducted a series of internal and external evaluations and research to: • …become more efficient and effective e.g. targeting, IT trace and track solutions • …develop new models of service to stakeholders, and • …continue to advocate and build upon our position of quality medicines for all

  7. NRA capacity building* • Part of the programme from the very beginning • Unique rotational post for developing country regulators • 2010 – 76 countries represented in WS (always sub-regional, regional or interregional) – regulators and manufacturers • Each assessment session – average 15 assessors from developing countries • Inspection – host country inspectors always invited, inspectors from recipient countries also involved • 22 prequalified QC laboratories covering all 6 WHO regions, +33 in different stages • Joint assessment with EAC countries * This is integral part of many WHO at activities at HQ, regional and country level. Other medicines programmes are also involved.

  8. Funding: past, present and future • Past funding – Canada, France, Germany, Ireland, Norway • Breakthrough – BMGF grant in 2006 • Present and future • Most significant – UNITAID • BMGF for RH products • Cost sharing/recovery • Support from GF, co-financing • Charging for service built into procedures • Internal issues

  9. Existing benefits for future development • As the world’s convener of medical and technical capabilities and moderator of major issues and stakeholder positions, WHO can give more people greater access to quality medicines • The programme has a solid technical foundation with a strong record of accomplishment Of all “regulatory pathways” PQP has the greatest upside potential of meeting the challenges of access to quality Essential Medicines

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