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Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report. 2011
Mei-Ling Chen, and
Vinod P Shah, and
Daan J Crommelin, and
Leon Shargel, and
Dennis Bashaw, and
Masood Bhatti, and
Henning Blume, and
Jennifer Dressman, and
Murray Ducharme, and
Paul Fackler, and
Terry Hyslop, and
Lorelei Lutter, and
Jose Morais, and
Eric Ormsby, and
Saji Thomas, and
Yu Chung Tsang, and
Raja Velagapudi, and
Lawrence X Yu
U.S. Food and Drug Administration, Silver Spring, Maryland, USA. meiling.chen@fda.hhs.gov
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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