Fol­low­ing in FDA's foot­steps, EMA plots tran­si­tion to re­view­ing raw clin­i­cal da­ta

The FDA of­ten touts the fact that it’s the on­ly drug reg­u­la­tor in the world to ac­tu­al­ly look at the “raw” clin­i­cal da­ta (i.e. in­di­vid­ual pa­tient da­ta) as part of its phar­ma­ceu­ti­cal app re­views, al­low­ing the agency to cut through what may be bi­ased, mis­lead­ing or in­cor­rect da­ta analy­ses/in­ter­pre­ta­tions by a spon­sor.

Now, the Eu­ro­pean Med­i­cines Agency said Tues­day it’s con­sid­er­ing a sim­i­lar ap­proach, as the EMA’s hu­man med­i­cines com­mit­tee (CHMP) cur­rent­ly re­ceives drug­mak­ers’ da­ta af­ter a com­pa­ny’s sta­tis­ti­cal work pro­vides the agency with clin­i­cal sum­maries.

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