Should the FDA emulate Europe's EMEA?

摘要

OXFORD, U.K.--Many U.S. biopharmaceudcal executives look enviously at Europe'sbiologic evaluation procedures, saying that they wish that the U.S. system was modeled on it. Indeed, many of these executives comment that---rather than being stuck with. the. gtecial pace of evaluation procedures at the Food and Drug Administration (FDA, Rockville, MD)--they would be happy with a U.S. copy of the European Medicines Evaluation Agency (EMEA, London) or its predecessor, the Committee for Proprietary Medicinal Products (CPMP, Brussels).