Effective 25 May 2021 the ICH guideline M9 “Biopharmaceutics Classification System-Based Biowaivers” is implemented by PQT/MED. This guideline provides an internationally harmonised approach for the classification of active pharmaceutical ingredients (APIs) within the Biopharmaceutics Classification System (BCS) and for BCS-based biowaivers from the requirement to conduct in vivo bioequivalence studies for drug products.
In line with the implementation of ICH Guideline M9, PQT/MED-specific annotations for the BCS-based biowaiver guideline and a revised application form for BCS-based biowaiver applications have been published. These documents provide clarity on the data requirements for a BCS-based biowaiver request within an application to the programme.
PQT/MED-specific guidance and a revised application form for additional strength biowaiver requests have also been published. These documents highlight PQT/MED-specific requirements for additional strength biowaiver requests based on the WHO bioequivalence guideline in Technical Report Series (TRS) No. 1003, Annex 6 (2017).