Expert Review Panel

In some instances, procurers are faced with a dilemma: neither a prequalified nor a stringently-approved finished pharmaceutical product (FPP) exists for a certain product. Yet the product is urgently needed for a treatment programme or for promoting reproductive health. The Expert Review Panel (ERP) was created by WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria to respond to this situation. An independent advisory body of technical experts coordinated by WHO, ERP uses transparent, science-based criteria to assess the quality risks of FPPs that are neither WHO-prequalified nor have been approved by a stringent regulatory authority. Assessment results are used to inform procurement decisions relating to (time-limited) procurement of the products assessed. To be eligible for ERP assessment, an FPP must generally be manufactured at a site that is compliant with WHO Good Manufacturing Practices. Information about calls for submission of FPPs for ERP assessment can be found in the Market Information section.

The principal users of the ERP mechanism are the Global Drug Facility, the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNFPA, UNICEF and WHO's procurement unit. But any procurer can request ERP evaluation of FPPs. (A fee is applied for evaluation of each FPP dossier and for evaluation of additional data, if this is required.)