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

5. 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

6. 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)

7. 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

8. 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.

9. 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

10. 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