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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.

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IGBA | INTERNATIONAL GENERIC AND BIOSIMILAR MEDICINES ASSOCIATION

C/O DYN SA
Rue de Cornavin 11
1201 Geneva, Switzerland

Telephone: +32 (0)2 5346607 (S. Kox)
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