Biopharmaceutics Classification System (BCS)-based Biowaivers

Effective January 1, 2025, PQT/MED will implement the use of the WHO guideline on Biopharmaceutics Classification System-based biowaivers (TRS 1052, Annex 7, 2024), replacing the ICH Harmonised Guideline M9 as the recommended guideline for consideration when proposing and evaluating a BCS-based biowaiver in an application to PQT/MED. 

The recently published WHO guideline and the ICH M9 guideline are very similar in most respects with regard to recommendations and requirements, however, there are differences between the guidelines with respect to excipient requirements for products containing BCS Class III APIs which should be noted by potential applicants to PQT/MED.