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The Impact of the EU Clinical Trials Directive and Other Recent Regulatory Changes on PD and the Manufacture of Biopharmaceuticals

Presented at: ISPE Tampa, Florida, February 20, 2006

This presentation contrasts the 2006 FDA GMP regulations in support of Phase 1 clinical trials with the effect of the European Union’s Clinical Trial Directive (EU CTD) on biopharmaceutical manufacturing strategies and costs. For Europe, the costly compliance issues now face companies wishing to conduct clinical trials in Europe, and these higher costs of compliance are likely to slow the growth of the biopharmaceutical industry in Europe and reduce the probability of discovering valuable new biologic compounds. The impact of the directive will depend on its interpretation by regulatory agencies; the most conservative interpretation may result in increased costs of entering early clinical development in Europe, forcing these development activities to other countries outside the EU. Further, the EU CTD may significantly affect manufacturing capacity for early stage clinical trial material, since facilities that have served this market may not be equipped to meet the more stringent requirements. The FDA is moving in the opposite direction to the EU in this area.