(2003; 148 pages)
3.3 Pharmacopoeial monographs on antiretrovirals
The Committee adopted the recommendations on the development of pharmacopoeial monographs on antiretrovirals made during a consultation held in Geneva in September 2001, but advocated that the Secretariat should review the list of substances and products in accordance with the new treatment pattern regimen. For a number of antiretrovirals, manufacturers’ specifications are available. The Committee therefore recommended that WHO should seek information from additional manufacturers willing to collaborate. It was suggested that national authorities with experience in evaluating and testing new antiretrovirals should be asked for their support. This also applies to the possibility of obtaining samples.
The following recommendations were made by the Expert Committee:
• Since the development and validation of analytical methods and requirements (including screening tests and pharmacopoeial monographs) as well as the establishment of International Chemical Reference Substances will require a significant budget, the possibility of obtaining financial support should be investigated.
• The development of quality specifications for substances and pharmaceutical products including one active pharmaceutical ingredient should be given priority.
• The collaboration of the PDG should be sought in elaborating monographs on antiretrovirals.