TRS 1044 - Annex 9: WHO/UNFPA guidance on natural rubber latex male condom stability studies
Annex 9, WHO Technical Report Series 1044, 2022
30 September 2022
| Technical document
Overview
Manufacturers of natural rubber latex male condoms are required by regulatory bodies to establish the shelf-life of their products prior to placing them on the market. The methods and data used to establish the shelf-life are assessed as part of the regulatory review processes. The United Nations Population Fund (UNFPA) also requires data supporting shelf-life claims to be submitted as part of the prequalification process for the procurement of natural rubber latex male condoms.
WHO Team
Access to Medicines and Health Products (MHP),
Health Product Policy and Standards (HPS),
Norms and Standards for Pharmaceuticals (NSP),
Technical Standards and Specifications (TSS)