Guidance

Manufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.

Guidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.

Assists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.

Guidance on how to provide the required patient information materials with all implantable and active implantable medical devices.

Guidance on submitting an effective prescription medicines application.

This guidance document provides information about when and how clinical decision support software is regulated in Australia by the TGA.

Guidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).

This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

Guidance on when and how to provide Product Information to us.

Guidance on bioavailability and/or bioequivalence aspects of prescription medicines including information on biowaivers.

Guidance to assist sponsors to understand the process for submitting a priority registration application.

Guidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).

Guidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.

Information on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.

Guidance on the evaluation process and information required for new registered complementary medicines.

Guidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

Guidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.

Guidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).

Guidance on provisional registration process for prescription medicines with provisional determination.

This guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.