IGBA applauds long-awaited scientific harmonization process of bioequivalence studies (December 2019)
The International Generic and Biosimilar Medicines Association (IGBA) welcomes the adoption by the International Council for Harmonization (ICH) of a new topic proposal on Bioequivalence for ImmediateRelease Solid Oral Dosage Forms (M13)i . The ICH Assembly approved the Concept Paper Outline in their November Singapore meeting with the establishment without delay of a new Working Group to initiate work on finalizing the concept paper and business plan for this new topic.