Guidance aims to further strengthen consensus on bioequivalence

3 July 2023

The general assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has adopted a new topic focused on the harmonization of bioequivalence for modified-release products.

This event took place at the ICH meeting in Vancouver, Canada, marking the introduction of a new ICH multidisciplinary guideline, which aims to further strengthen consensus and harmonization among ICH members regarding bioequivalence standards for more complex dosage forms.

"We can unlock the full potential of affordable and quality-assured medicines"The move has been welcomed by the International Generic and Biosimilar Medicines Association (IGBA) which sees the scientific harmonization of study designs for bioequivalence studies involving modified-release products as holding great promise for streamlining important aspects of trial conduct and optimizing product development.

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