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Facts and figures for 2010
Evaluation of medicines by the WHO Prequalification of Medicines Programme (PQP) includes assessment of data and information on safety, efficacy and quality. Inspections are performed to assess compliance with good manufacturing practices (GMP) and include manufacturers of selected active pharmaceutical ingredients (API) and clinical sites. Clinical sites, including contract research organizations (CROs), are also inspected to verify bio-equivalence with good laboratory practices and good clinical practices.
Thirty-six products were prequalified in 2010, of which 30 were generics. At the end of 2010, the WHO list of prequalified medicines totalled 252 products manufactured in 20 countries. WHO prequalifica-tion "firsts" included artesunate powder for injection (which was the first prequali-fied sterile product made in China); the first combination tenofovir disoproxil fumarate/lamivudine and the first generic emtricitabine.
Six medicines quality control laboratories (QCLs) were also prequalified: one in Bolivia, one in Canada, one in Peru, two in Ukraine and one in Uruguay. At the end of 2010, a total of 17 QCLs had been prequalified and a further 30 were working towards becoming prequalified.
Invitations to manufacturers to submit an expression of interest (EOI) for product evaluation were issued for anti-TB medicines, HIV/AIDS-related care and treatment products, and reproductive health products. The new invitations incorporate additional products and/or take into account revisions made to WHO treatment guidelines. Additionally, the first invitation to manufacturers of active pharmaceutical ingredients (APIs) was issued in October 2010, marking the launch of WHO prequalification of APIs. (A second, expanded invitation to API manufacturers to submit an EOI was issued in March 2011.) It is expected that time taken to reach prequalification will be shorter for finished pharmaceutical products (FPPs) that are manufactured using WHO-prequalified APIs, than for FPPs that are manufactured using APIs that have not previously been evaluated by WHO PQP.
Assessment activities
In 2010, 51 dossiers were submitted and 53 dossiers (two of which were received in late 2009) were accepted for evaluation. Nearly 1000 assessment reports were produced. PQP also assessed nearly 600 variations submitted by manufacturers of prequalified products.
The assessment sessions held in Copenhagen, Denmark, include a training component which is enabling a growing number...