Scientific and technical requirements to formulate a female condom generic specific specification and prequalification scheme
There are several new female condom products in various stages of development, of which, some have entered the market. To date, however, only one product has been approved for bulk procurement for public sector programmes. Manufacturers of these new female condoms urgently need support and guidance to enable them to undertake the required research, quality assurance testing and clinical trials for country regulatory and bulk procurement approvals. In December 2010, the World Health Organization, Department of Reproductive Health and Research (RHR). The United Nations Population Fund (UNFPA) and FHI 360 convened a workshop for manufacturers, donors and international agencies to review and discuss the requirements and procedures to produce and procure quality-assured female condoms for the public sector and social marketing of female condoms.