WHO Biowaiver Project Cycle VII (2025) and Results from Cycle VI (2024)

Recommendation

1/2 July 2025
Berlin, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

The World Health Organization (WHO) has published a draft working entitled WHO Biowaiver Project - Prioritization exercise of active pharmaceutical ingredients for cycle VII (2025) and preliminary results from cycle VI (2024) (QAS/24.966).

Biowaivers are a way of waiving bioequivalence studies in human, which means that they are not considered necessary for product approval. This document is intended to support the prioritization exercise of APIs to be characterized in their solubility profile in cycle VII of the WHO Biowaiver Project and present the preliminary results from cycle VI.

Content of the Document

The working document starts with a brief background section, providing an overview of the project’s development. The main document is divided into the following three sections:

Introduction
The revised WHO Biowaiver List
Prioritization exercise of active pharmaceutical ingredients for Biopharmaceutical Classification System-based classification in WHO Biowaiver Project

This is followed by a list of references and further reading.

The document was posted on the WHO Medicines website under "Working documents in public consultation".