Resources

Everyone can play an important role in monitoring the safety of therapeutic goods in Australia.

Effective 1 October 2018 TGA has made a new determination which excludes certain goods from the operation of the Act

Compositional guideline for Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines.

Compositional guideline for 'Demineralised fish proteoglycan extract' permitted for use in listed medicines

Approved PI and CMI documents for OTC medicines can now be published on the TGA website

Guidance for applicants on how to request and prepare for pre-submission meetings.

How to apply for inclusion of face masks (including respirators), that are medical devices, in the Australian Register of Therapeutic Goods (ARTG).

Guidance on providing Product Information

We have published a social media acceptable use policy that advertisers can use on their digital platforms.

Find further information about inspection and audit feedback forms. On this page they are available in pdf and Microsoft Word formats to download.

Covers the general principles of market authorisation and the process of getting approval to supply a therapeutic good

Application phases for a new registered complementary medicine

Answers common questions.

overview of identification of herbal materials and extracts

TGA Laboratory testing - Contamination of ranitidine medicines with the nitrosamine NDMA

Compositional Guideline for Bacillus subtilis strain NRRL B-67989 permitted for use in listed medicines.

The TGA has made a section 7 declaration to declare that certain sports supplemenst are therapeutic goods

Changes to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG

Information on quality for the medicine/finished product

Covers the general principles of advertising requirements for therapeutic goods and includes two case studies

The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products (the Code) applies to Blood, Human Tissues and Human Cellular Therapy Products manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance of Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.

This document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.

The OTC application categorisation framework defines the different OTC medicine application levels and identifies the key application criteria

Import/export of unapproved therapeutic goods for experimental purposes