Generics Industry Welcomes Fresh ICH Harmonization Initiative

IGBA Lauds Plans For Guideline On Bioequivalence For Modified-Release Products

The International Council for Harmonisation has unveiled plans to develop and publish several new guidance documents, including one on bioequivalence for modified-release products, which has been welcomed by global off-patent industry body the IGBA.

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The ICH has outlined plans for a guideline on bioequivalence for modified-release products • Source: Shutterstock

Plans announced by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop and publish a guideline on bioequivalence for modified-release products have been commended by the International Generic and Biosimilar Medicines Association (IGBA).

Bioequivalence for modified-release products was one of three new areas for harmonization that the ICH assembly adopted

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