TRS 1025 - Annex 12: WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
WHO Technical Report Series, no. 1025
20 April 2020
| Technical document
Overview
The aim of the WHO Biowaiver List is to enable an informed decision on whether or not a waiver from in vivo bioequivalence studies could be granted safely according to the WHO guidance Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (1).
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)
Copyright
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