The United Nations Population Fund (UNFPA) has issued its 14th 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 injectable hormonal contraceptives, oxytoxics, and treatment for maternal syphilis and prevention of congenital syphilis.
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. This is because WHO’s unit for Regulation of Medicines and other Health Technologies (RHT), and the Global Fund to Fight AIDS, Tuberculosis and Malaria created a mechanism, known as the Expert Review Panel (ERP). ERP provides risk-based advice to support decisions about procurement of products that have not yet been prequalified or received stringent approval but that are in the WHO Prequalification Team: medicines pipeline or that of a stringent regulator.
Each ERP is a discrete operation, consisting of an invitation to manufacturers to submit a product(s) for ERP evaluation. Products submitted undergo technical review of potential quality risks, based on the information contained in their product dossiers. ERP thus enables procurement organizations to make evidence-based decisions regarding procurement of the products concerned.