The lack of prequalified reproductive health medicines is of great concern to WHO and to partner organizations working to improve reproductive health. However, lack of prequalified products – irrespective of therapeutic category – does not necessarily impede supply of products in the short term since WHO’s Quality and Safety: Medicines team (now Regulation of Medicines and other Health Technologies - RHT), and the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) have created a mechanism known as the Expert Review Panel (ERP), that provides risk-based advice to aid decisions about procurement of products that are in the Prequalification Team - Medicines (PQT) or other stringent regulatory “pipeline”, but that have not yet been prequalified or SRA approved. Each ERP is a discrete operation, consisting of an invitation to manufacturers to submit a product(s) for ERP evaluation. This is followed by technical review of the potential quality risks for each individual product, based on the information contained in the dossier submitted for that product. ERP’s objective is to enable procurement organizations to make evidence-based decisions regarding procurement of the products submitted for evaluation.
The United Nations Population Fund (UNFPA) has issued its 11th Invitation to Manufacturers of Reproductive Health Medicines to Submit an Expression of Interest (EOI) for Product Evaluation by the WHO Expert Review Panel (ERP) for Reproductive Health Medicines. Products invited for evaluation include oral hormonal contraceptives, injectable hormonal contraceptives, implantable contraceptives, oxytoxics, and products for prevention and treatment of eclampsia.