The female condom has the advantages that it is controlled by the woman and can be inserted several hours before intercourse. It is gradually gaining in popularity, and new products are appearing on the market.
The Department of Reproductive Health and Research (RHR) works with its partners to support the research, design, development, safety, efficacy, quality assurance, regulation, procurement and promotion of female condoms.
Developping generic specific specification and prequalification scheme for procurement of female condoms
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.
Scientific and technical requirements to formulate a female condom generic specific specification and prequalification scheme
The WHO/UNFPA Female Condom Technical Review Committee
First convened in 2006, the mandate of the committee was to review the evidence on female condom failure modes to correct and harmonize the multiple definitions, draft and publish the definitions for female condom failure modes. The Committee also formulated a review criteria and structured a process to review the design, clinical issues and technical issues, manufacturing process and quality assurance and testing processes for three female condoms submitted for review. This process resulted in the prequalification of one female condom – the FC2.
Considerations regarding reuse of the female condom
WHO recommends use of a new male or female condom for every act of intercourse where there is a risk of unplanned pregnancy and/or sexually transmitted infection, including HIV. Since access to female condoms may be limited and reuse of female condoms has been reported, WHO has convened two consultations to address considerations regarding such reuse.