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CHMP Advises Drug Sponsors on Foreign Study Data
December 17, 2009
As more clinical trials are conducted outside the EU, sponsors seeking approval from the European Medicines Agency (EMEA) should take into account several
factors that could affect the applicability of their data and address them early, the Committee for Medicinal Products for Human Use (CHMP) says. Includes the full text of CHMP Reflection Paper on Extrapolating Trial Results.
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