Resources

Compositional Guideline for calcium fructoborate tetrahydrate permitted for use in listed medicines.

Compositional Guideline for Cyclocarya paliurus leaf extract dry.

Answers to frequently asked questions in relation to the pharmacovigilance obligations of sponsors of medicines on the ARTG

Compositional guideline for '3-Fucosyllactose' permitted for use in listed medicines

Explanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.

This form is to assist users of the Electronic Lodgement Facility (ELF) seeking preclearance for animal derived ingredients by detailing what the TGA is looking for and what supporting documents need to be provided.

Information about breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) for health professionals.

All surgical procedures carry risk. A page for consumers considering getting implants.

User guide on how to submit data in the electronic Common Technical Document (eCTD) format.

Information on how we review applications for registration of mRNA vaccines which are variations on existing mRNA vaccines designed to confer protection from newly identified variants of concern (VOC).

Use this form to request reinstatement of a cancelled entry on the Australian Register of Therapeutic Goods

Compositional guideline for 'Protease' permitted for use in listed medicines

FAQs for health professionals importing and supplying medical devices

In 2022, the TGA initiated targeted compliance reviews for listed medicines that require warning statements on the label based on their inclusion of the herbal ingredients Foeniculum vulgare (fennel), fennel bitter seed dry, fennel sweet seed dry and/or fennel oil.

How the Therapeutic Goods Administration (TGA) defines and regulates listed disinfectants, including guidance on how to submit a product application and the supporting data and other information required.

Compositional guidelines for 'Chicken Sternum Cartilage Powder' permitted for use in listed medicines.

Compositional guideline for 'Refined Buglossoides arvensis seed oil' permitted for use in listed medicines.

Notification form for lapses in medical device conformity assessment certification now available on the TGA Consultation Hub

Our approach to delays in overseas and Australian conformity assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.

Frequently asked questions to further clarify the new regulatory framework for personalised medical devices

Compositional guideline for 'Galactooligosaccharides' permitted for use in listed medicines

Apply to import and supply substitute medicines under section 19A

How to use the ADR reporting template in the Best Practice software

N2 applications involve reduced requirements for data assessment by the TGA and consequently shorter evaluation timelines.

Compositional guideline for 'Calanus finmarchicus oil' permitted for use in listed medicines