Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report |
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Authors: | Chen Mei-Ling Shah Vinod P Crommelin Daan J Shargel Leon Bashaw Dennis Bhatti Masood Blume Henning Dressman Jennifer Ducharme Murray Fackler Paul Hyslop Terry Lutter Lorelei Morais Jose Ormsby Eric Thomas Saji Tsang Yu Chung Velagapudi Raja Yu Lawrence X |
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Institution: | Office of Pharmaceutical Science, Center forDrug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA. meiling.chen@fda.hhs.gov |
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Abstract: | Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products. |
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