The WHO Prequalification of Medicines Programme (PQP) was launched in 2001,
in partnership with UNAIDS, UNICEF and UNFPA, with support from the World Bank.
Its focus was evaluation of medicines for treating HIV/AIDS, malaria and
tuberculosis (TB). Products in other therapeutic categories are now also
evaluated.
The Programme reviews product dossiers, including data and information on
safety, efficacy and quality, and inspects manufacturing sites, to assess
compliance with good manufacturing practices (GMP). It also inspects clinical
sites, including contract research organizations (CROs), to verify compliance
with good clinical practice (GCP) and good laboratory practices (GLP), with
respect to bioequivalence studies. It also prequalifies medicines quality
control laboratories (QCLs).
For further information on medicines and QCL prequalification go to:
http://www.who.int/prequal