Review on Regulator’s Perspective of TGA about Pharmacovigilance during Premarketing and Post Marketing of Medicinal Product

Authors: Vaishnavi A*

DOI: 10.23880/apct-16000249

Volume 9, Issue 3

Abstract

The Review is about Therapeutic Goods Administration (TGA) which is a regulatory authority responsible for ensuring the safety, quality, and efficacy of therapeutic goods in Australia and how it works during the premarketing and post marketing of medicinal products. It clearly explains about the responsibilities of TGA in evaluation of drug safety data during pre-marketing and post-marketing phases, the implementation of risk management plans, and the facilitation of effective communication channels for adverse event reporting.

Keywords: Pharmacovigilance; Premarketing; Post Marketing; Medicinal Product; Risk Management; Australian community; Therapeutic Goods

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