The formal adoption by the International Council for Harmonization’s general assembly of a new topic on bioequivalence for immediate-release solid oral dosage forms has been welcomed by the International Generic and Biosimilar Medicines Association. During its most recent meeting held in Singapore last month, the ICH assembly agreed a concept paper outline for the M13 bioequivalence topic and decided to establish “without delay” a new working group to work on finalizing the concept paper and devise a business plan.
Global Industry Hails Bioequivalence Progress
ICH Working Group Starts Devising Plan
For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.
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