FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

ICH Starts Work on Two Multidisciplinary Drug Development Guidelines

Oct. 26, 2016

The International Council for Harmonisation has begun work on two global, multidisciplinary guidelines for drug development: one on waiver policies for bioequivalence studies, and the other on validation of scientific analytical methods.

The first draft guideline, known as M9, is expected to recommend an international standard of classifying drugs as either highly or poorly soluble, and to explore the different methods of estimating permeability — such as whether estimates should be based on in vitro data, in vivo data or both — and to identify proper cut-off values for considering a product either highly permeable or poorly permeable.

Current biowaiver policies — under which efficacy and safety portions of applications can be approved based on evidence of equivalence, rather than through new in vivo testing — are not recognized worldwide in all cases.

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