This is a helicopter view of the regulatory requirements to gain approval for a prescription medicine in Australia. For detailed information it’s best to refer to the Therapeutic Goods Administration (TGA) website.

In order to be able to sell a therapeutic good in Australia it’s necessary to have the product included on the Australian Register of Therapeutic Goods (ARTG). In broad terms, the process of gaining approval involves submitting a scientific data package (dossier) to the TGA for evaluation. The TGA critically evaluates the dossier to determine if the medicine is of acceptable quality; if it’s safe for use and is effective in the treatment or prevention of the specified medical condition.

The person or company (termed Sponsor) needs to submit a dossier in the Common Technical Document (CTD) format. This is a internationally harmonised format which is recognised in countries including Europe, the United States and Japan. The CTD is comprised of five modules:
• Module 1: Includes the Administrative data such as evidence of Good Manufacturing Practice (GMP) and draft Product Information and Consumer Medicine Information (CMI)
• Module 2: Summarises the information and includes critical appraisals of the data in Module 3, 4 and 5. It’s effectively a summary of all the scientific data supporting the registration of the prescription medicine
• Module 3: Quality data – which includes details on the manufacturing process, stability data, testing methods and controls; this is commonly referred to as Chemistry, Manufacturing and Controls (CMC)
• Module 4: Non-Clinical data includes all the testing which have involved the use of animals to demonstrate that the product is safe
• Module 5: Clinical data – includes all the clinical trials which have been conducted with the prescription medicine to demonstrate that the product is safe and effective

Collectively this information provides the regulator with all the relevant data to determine that the benefit of taking the medicine outweighs the risk.