Overview of the ICH-M9 Guideline: Biopharmaceutics Classification System (BCS) -based Biowaiver

Abstract

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) -M9 guideline (Biopharmaceutics Classification System[BCS]-based biowaiver) has been implemented in Japan. This guideline proposes the concept that a bioequivalence study is waived through evaluation of drug properties (solubility and permeability) and formulation characteristics (excipients and in vitro dissolution). The BCS-based biowaiver is expected to be used for the application of formulation changes and new generic drug development. Although the M9 guideline harmonized primary requirements for BCS classification and formulation characteristics, further discussions on standardization of solubility measurement and judgment methods for dissolution similarity, and on the permitted differences in excipients are needed. In this article, we present an overview of the guidelines, the current situation in different regions worldwide, and the scientific issues to be resolved.