CHMP: Sponsors Should Consider Factors in Extrapolating Data

Sponsors wanting to extrapolate data from drug trials conducted outside the EU for marketing approval within the EU need to address several factors that could affect the applicability of the data, the Committee for Medicinal Products for Human Use (CHMP) says. Three major factors to consider are differences in medical practice, disease definition and the study population, CHMP says in a reflection paper posted on its website.
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