1. Why does WHO run the Prequalification of Medicines Programme?

2. WHO prequalification of medicines is a service provided by WHO to assess the quality, safety and efficacy of medicinal products.

3. The other vaccine (Shanchol) is pending WHO prequalification and provides longer-term protection against V. cholerae O1 and O139 in children under five years of age.

4. The WHO Prequalification of Medicines Programme (PQP) ensures that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.

5. These procedures make the WHO prequalification process the most transparent of all similar quality assurance programmes to date.

6. The WHO prequalification of medicines process can take as little as three months, provided the data presented are complete and demonstrate that the product meets all required standards.

7. Prequalification is intended to give these agencies the choice of a wide range of quality medicines for bulk purchase.

8. The WHO Prequalification Project is providing vitally important support for the effort to make the necessary drugs and diagnostics available.

9. Thus, prequalification becomes the key issue in construction surety bond.

10. In 2008, prequalification of zinc – for the management of acute diarrhoea in children – was added.

11. We aggressively promote them, whether through guidelines for conducting bioequivalence studies or through the prequalification programme.

12. An improved process is needed in order to better meet the challenges of the increasing volume and complexity of prequalification requests from manufacturers.

13. It drove the construction of a physical and management infrastructure of supply chains, prequalification systems, protocols for treatment, diagnosis, and case management.

14. A list of WHO-prequalified antimalarial medicines can be obtained from the webpage of the WHO Prequalification Programme.

15. Assistance is delivered by specialists who are not involved in WHO prequalification assessment or inspection activities, but who can conduct audits and training at country-level.

16. Only products included in an EOI are eligible for prequalification.

17. A vaccine for Japanese encephalitis which will be submitted shortly to WHO for prequalification.

18. Their addition to the list reflects considerable quality improvement made by manufacturers, and an increasing interest in being part of the prequalification programme.

19. This performance evaluation will also inform procurement and prioritization for diagnostic test entry into WHO Prequalification Diagnostics Programme and WHO Procurement Schemes.