Resources

Improved CMI templates and resources

Instructions for applicants on how to organise and fill out a pre-submission planning form (PPF).

External evaluators are required to use their expertise to review the data provided by sponsors and prepare an assessment report.

Test procedures for starting materials used in complementary medicines must use analytical methods that are validated for that purpose.

Device Requirements version 4 (DR4) provides guidance on transition arrangements for 'retained registered disinfectants'
regulated under the pre- 4 October 2002 regulatory framework for medical devices.

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

This user guide is for sponsors applying to change the entry in the ARTG for a registered non-prescription over-the-counter (OTC) medicine

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.

OTC application placement flowchart

Medicine safety issue notification form for sponsors

Information on how to compile a literature based submission (including mixed applications).

User guide updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.

User guide for sponsors of medical devices.

User guide for sponsors and manufacturers wanting to submit data in the NeeS format.

We have published updated guidance for OTC medicines to better assist applicants to register or make a change to a registered OTC medicine

The OTC Dossier Documents Matrix (the 'matrix') provides a summary of which documents are required for each application level (N1, N2, N3, N4, N5, C1, C2, C3 or C4)

Determining the route for an over-the-counter (OTC) application and assessing the risk to consumers with the umbrella brand extension.

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

This form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.

You must submit this notice before you import a cannabis vaping device or accessory.

A checklist for sponsor intending to supply a therapeutic vaping device

You must submit this notification to the TGA to qualify as a transitional manufacturer and be exempt, between 1 January 2024 and 1 December 2024, from the requirement to hold a manufacturing licence for therapeutic vaping goods.

This guidance intends to outline for sponsors and manufacturers the types of RWE relevant in the Australian context.

The ARGLMRCM presents guidance in separate documents to facilitate timely updates.

describes the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines