EMA欧洲药品管理局医疗产品指南.pdf

18October2018

CPMP/EWP/239/95Rev.1,Corr.1*

CommitteeforMedicinalProductsforHumanUse(CHMP)

Guidelineonequivalencestudiesforthedemonstrationof

therapeuticequivalenceforlocallyapplied,locallyacting

productsinthegastrointestinaltract†

DraftagreedbyGastroenterology

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