Therapeutic Goods Administration (TGA)

We are Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. We regulate medicines, medical devices and biologicals to help Australians stay healthy and safe.

Highlights

GMP Forum 2024

19 November 2024

Workshops

Registrations are open for the GMP Forum 2024! 19-20 November, Melbourne Convention and Exhibition Centre. Purchase your tickets through the GMP Forum 2024 event website.
Medicines containing Garcinia gummi-gutta (Garcinia cambogia) or hydroxycitric acid (HCA)

8 August 2024

Safety alerts

We have become aware of an increasing number of cases of liver injury reported in scientific literature, by consumers who had taken products containing Garcinia gummi-gutta.
Guidance changes are coming soon

7 August 2024

News

Some changes are rolling out soon to improve your experience using guidance on our website. We’re aiming to make our content clearer, more accessible and easier to navigate.

Top tasks

Search for health products on our register

Search the Australian Register of Therapeutic Goods (ARTG) by name, ID or sponsor. Search results from the ARTG include Consumer Medicine Information (CMI) and Product Information (PI). Not all CMI and PI documents are available on this website.

Frequently searched by industry

Frequently searched by health professionals

Latest alerts

Counterfeit Ozempic pens detected and adverse event reported

30 September 2024

Safety alerts

Consumers and health professionals should be aware that counterfeit Ozempic-labelled pens have been imported into Australia. These pens may pose a serious health risk and should not be used. There are clear inconsistencies from the original product to look out for.
Substitution allowed to address shortage of Ryzodeg 70/30 FlexTouch insulin - September 2024

27 September 2024

Medicine shortage alerts

We have made a new Serious Scarcity Substitution Instrument to help manage the shortage and upcoming discontinuation of Ryzodeg 70/30 FlexTouch insulin.
Update on supply of Mounjaro (tirzepatide) injections

26 September 2024

Medicine shortage alerts

The new KwikPen presentation of Mounjaro is now available but supply of all strengths of Mounjaro vials remains limited.

Latest news and updates

Updates to the Prescribing Medicines in Pregnancy database - September 2024

2 October 2024

News

The Prescription Medicines in Pregnancy database has been updated to include new and amended entries.
Enhanced product standards for therapeutic vapes in 2025

1 October 2024

Media releases

We are introducing strengthened product standards for therapeutic vapes including vaping substances, vaping substance accessories, vaping devices and vaping device accessories.
Therapeutic vapes available without a prescription following consultation with a pharmacist

1 October 2024

Media releases

Patients 18 years or over can purchase therapeutic vapes from participating pharmacies without a prescription. A consultation with a pharmacist is required, and purchase is subject to certain conditions as well as any state and territory restrictions.

Open consultations

Consultation: Draft Guidance - Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin

Closes on 9 October 2024

Consultation

We are seeking feedback on draft guidance documentation 'Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial, or recombinant origin - guidance on the new regulatory requirements and transition arrangements'.
Consultation: Future regulation of assistive technologies

Closes on 13 October 2024

Consultation

The TGA is seeking feedback on proposed changes to the regulation of assistive technologies.
Consultation: Clarifying and strengthening the regulation of Artificial Intelligence (AI)

Closes on 13 October 2024

Consultation

This consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2024

Closes on 18 October 2024

Consultation

This consultation is for interim decisions made in relation to substances that were discussed at the JUNE 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS).
Consultation: Proposed amendments to the Poisons Standard – ACMS and Joint ACMS-ACCS meetings, November 2024

Closes on 22 October 2024

Consultation

Have your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Medicines Scheduling (ACMS), meeting of the Advisory Committee on Chemicals Scheduling (ACCS), or a joint meeting of these two committees.
Consultation: Medical Devices - Essential Principles for Safety and Performance

Closes on 13 November 2024

Consultation

Have your say on the proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles). Closing date has been extended from 16 October to 13 November 2024.

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Therapeutic Goods Administration (TGA)

Highlights

GMP Forum 2024

Medicines containing Garcinia gummi-gutta (Garcinia cambogia) or hydroxycitric acid (HCA)

Guidance changes are coming soon

Top tasks

Report a problem or side effect

Safety alerts

Shortages

Recall actions

Database of Adverse Event Notifications (DAEN)

Medicinal cannabis hub

Entering Australia

Search for health products on our register

Frequently searched by industry

Guidance and resources

TGA Business Services (TBS)

How to advertise

Frequently searched by health professionals

Vaping hub

Prescribe an unapproved therapeutic good (health practitioners)

Personalised medical devices

Latest alerts

Counterfeit Ozempic pens detected and adverse event reported

Substitution allowed to address shortage of Ryzodeg 70/30 FlexTouch insulin - September 2024

Update on supply of Mounjaro (tirzepatide) injections

Latest news and updates

Updates to the Prescribing Medicines in Pregnancy database - September 2024

Enhanced product standards for therapeutic vapes in 2025

Therapeutic vapes available without a prescription following consultation with a pharmacist

Open consultations

Consultation: Draft Guidance - Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin

Consultation: Future regulation of assistive technologies

Consultation: Clarifying and strengthening the regulation of Artificial Intelligence (AI)

Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2024

Consultation: Proposed amendments to the Poisons Standard – ACMS and Joint ACMS-ACCS meetings, November 2024

Consultation: Medical Devices - Essential Principles for Safety and Performance