(2003; 148 pages)
10.2 Procedure for assessing the acceptability for purchase of pharmaceutical products for the treatment of HIV/AIDS
The Committee was informed of WHO’s pilot project, in conjunction with the United Nations Children’s Fund (UNICEF), the Joint United Nations Programme on HIV/AIDS (UNAIDS), and the United Nations Population Fund (UNFPA), together with the support of the World Bank, to test the system for the pre-qualification of suppliers of drugs for the treatment of HIV/AIDS. This included: (1) evaluation of the dossier; (2) provision of samples for analysis; and (3) inspection of the manufacturing site. Only manufacturers of dosage forms would be subject to inspection under this programme (manufacturers of active pharmaceutical ingredients would not be inspected at this time but such inspections are not excluded in the future). The Committee was briefed on the number of quality defects found in the course of this project, and recommended that every effort should be made to ensure budgetary support for its continuation.