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Drug Product Registration and Regulatory Requirements in Australia (TGA)

Praveen Agarwal, Mudit Dixit, R Narayana Charyulu, Deepak Bhandary


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 substance and product in the Australia, market is known as drug substance and product approval. Further, as per TGA regulation, prescription drugs are evaluated by the Drug Safety and Evaluation Branch (DSEB) and there are three categories of applications, commonly known as Category 1: Applications include new chemical entities, new biological entities, new combination products, extension of indications, major and minor variations, and new generics. Category 2: Applications supported by previous approvals and independent evaluation reports, from two acceptable countries. Category 3: Applications involving changes to the quality data of medicines already included on the ARTG. However in the opinion of the TGA, it does not need to be supported by clinical, non-clinical or bioequivalence data. All the information with respect to drug product has been complied in the form of dossiers. Dossier means a set of applications that include the clinical data, administrative information and quality data. To get a marketing authorization of drug product in Australia, the manufacture(s) has to be planned carefully with high quality of documents and supporting data as well as complete submission dossiers as per TGA rules and norms. The role of manufacture of drug product is very vital during the submission of drug product to ensure submission(s) meet the TGA submission rules and requirements in term of dossiers format and content.


Keywords: TGA, Drug Approval, Application Category, Dossier, CTD

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