TRS 1044 - Annex 9: WHO/UNFPA guidance on natural rubber latex male condom stability studies

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.