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Drug Product Registration and Regulatory Requirements in Australia (TGA)By Praveen Agarwal, Mudit Dixit, R Narayana Charyulu, Deepak Bhandary
Abstract: The present study aims to understand the drug product regulatory requirements and drug product registration process in Australia. Therapeutic Goods Administration (TGA) is the regulatory authority for Australia and is responsible for regulating medicines and medical devices. However, as known, each country has its own regulatory agency to enforce the rules and regulate the guidelines to market a drug substance and drug product. To get authorization of marketing of drug …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 2, Issue 1, 2015 · pp. 7–15 Read article →