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DRUG APPROVAL PROCESS ACROSS THE UNITED STATES, EUROPEAN UNION (ITALY), AND CANADA
Tanvi More M. S.* and Isha Joshi M. S.
ABSTRACT
This study highlights the Drug approval pathways across the USA (USFDA), Europe (EMA) and Canada (Health Canada). USFDA and Health Canada follow a centralized procedure. Hence, in the US and Canada, clinical trials and market Approval are conducted solely under the supervision of FDA and Health Canada respectively whereas The European Union follows centralized, decentralized or mutual recognition procedure So clinical trials and market approval are conducted at the member state level. In this paper, we have compared drug approval processes (Submissions), labeling requirements and Keywords: FDA, EMA, Health Canada, Pharmacovigilance [Download Article] [Download Certifiate] |