TRS 1060 - Annex 5: WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
15 April 2025
| Technical document
Overview
The aim of the WHO Biowaiver List is to enable an informed decision as to whether or not a waiver from in vivo bioequivalence studies could be granted safely according to the WHO guideline on Biopharmaceutics Classification System based biowaivers (1).
The WHO Biowaiver List is expected to promote access to standard-quality essential medicines by shortening the time required to develop a multisource (generic) product supporting an optimized pharmaceutical development.
The WHO Biowaiver List has been recognized by WHO regional and country offices as a “global good” – a normative work essential to strengthening global health in WHO Member States.
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)
Number of pages
14