Abstract

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
pharmacovigilance activities across these countries. These differences cause hurdles in getting drugs with great therapeutic potential into commercial distribution internationally.To rectify this anomaly, collaborative efforts have been initiated by their Regulatory agencies and Federal organizations to harmonize the drug approval process globally.

Keywords: FDA, EMA, Health Canada, Pharmacovigilance