Sunscreens – see below in Cosmetics and Sunscreens section

TGA is modernising its digital systems – information about how you can interact with the TGA is here.

TGA Compliance and education for listed medicines – current priorities updated 8th April, includes

* Stability requirements for listed medicines (published January 2025)

* Efficacy of listed medicines for exercise performance (published November 2022)

More information here.

Compliance management enforcement – how does the TGA approach and manage compliance with therapeutic goods regulation in Australia? Details here.

Is information I publish about therapeutic goods considered advertising? The TGA has a guideline here. You may also consider doing our excellent course Advertising medicines and medical devices – a great course presented by an ex TGA adverting person.

TGA compliance principles 2026 and 2027 – read more here.

Andrographis paniculata

* The TGA has completed an updated safety review with in depth analyses of adverse event data up to 31 December 2024, and a supplementary report considering adverse event data up to 31 December 2025, of the herb and the risk of anaphylaxis. A detailed summary is here.

* Consultation has begun with stakeholders as to whether Andrographis paniculatashould be removed from the list of permitted ingredients. Source: TGA

(Editor’s comment: professionals working with Andrographis suggest the evidence available does not justify its removal from the permitted ingredients list)   

Pre-submission meetings with the TGA. These can be useful when proposing new herbal substances or other issues that affect complementary medicines. How to prepare for a meeting, and alternatives to a pre-submission meeting are discussed here.

Application to amend the Poisons Standard – new version of the form is available hereand you are invited to provide feedback by 10 July. More here.

Manufacturer statutory declarations. A statutory declaration is a written statement allowing a person to declare something to be true. Giving false or misleading information as part of a statutory declaration is a criminal offence. This webpage provides information on when a statutory declaration should be provided.

Unapproved medicines

* it is an offence to supply unapproved medicines, but you can apply for consent to import, supply or export therapeutic goods that do not comply with standards .. Source: TGA

* Information for healthcare practitioners – includes who can import therapeutic goods; parallel imports; and responsibilities of health practitioners. Source: TGA

* Consents to import, supply or export therapeutic goods that do not comply with standards – see a list of products here.

List of TGA licensed manufacturers – updated 4th May.

* The granting of 14 manufacturing licences. For further details, refer to Granted licence decisions for Australian manufacturers

* The suspension of 2 manufacturing licences. For further details, refer to Suspended licence decisions for Australian manufacturers

* The revocation of 8 manufacturing licences. For further details, refer to Revoked licence decisions for Australian manufacturers

GMP Clearance – The backlog of GMP Clearance Compliance Verification applications is continuing to reduce. Updates (22 April) information is here.

Peptides: are you importing, compounding and supplying unapproved peptide products? This TGA information page contains information you must read!

TGA’s freedom of disclosure (FOI) log – last updated 24th April 2026, is here.

Medicines and medical devices that have been cancelled or suspended and no longer appear in the ARTG – updated 16th April, published here.

Listed medicine compliance reports – no update since 31st March.

Compliance activity – Compliance enforcement

* The Federal Court of Australia has ordered Key Promotional Products to pay $1,750,000 for the unlawful import and supply of over 240,000 COVID-19 detection rapid antigen test kits. Mr Craig Shane Harding was also ordered to pay $250,000 for his role in aiding and abetting KPP’s conduct. The Court found that KPP made over 2,300 false or misleading representations in claiming that the RATs were ‘TGA Approved’. The total penalty was $2 million. Source: TGA

* Three Victorians arrested and charged following seizure of over $2 million worth of steroids and peptides by the Australian Borer Forces and TGA. The agencies seized a combined total of over 10,000 vials and 600 tablets. More details here.

Safety advisory: TGA Laboratory has tested a product labelled Artri Ajo King and found that the tablets contained undeclared diclofenac and dexamethasone which when taken either alone or in combination with other medicines, can cause serious side effects. Source: TGA

Infringement notices:

* We publish infringement notices every month in this newsletter. This webpage allows you to view previously issued infringement notices.

* 4 infringement notices totalling $79,200 were issued to Switch Nutrition for alleged unlawful advertising of therapeutic goods containing Nicotinamide Mononucleotide (NMN) and Vitamin D3 (Cholecalciferol) for the treatment of serious medical conditions. Source: TGA

Enforceable direction: Veganic SKN sunscreens – see below

Adverse event notifications: database last updated 27th March, includes medicines and medical devices – read it here.

Product corrections

* GlaxoSmithKline is issuing a product correction for certain batches of their Flixotide and Pavtide Accuhalers as a small number of Accuhalers may not automatically reload the next dose – read more here.

* Boston Scientific is conducting a Product Correction and Product Alert for ACCOLADE and VISIONIST pacemakers – an increased risk of permanently entering Safety Mode which has limited functionality. Details here.

Advisory Committee on Medical Devices: updates include:

* An application for a hip replacement device (considered at ACMD 86) has been rejected

* An application for a device for abdominal surgery (considered at ACMD 86) was withdrawn

* An application for a permanent cardiac implant (considered at ACMD 87) was withdrawn

The committee considered:

* A device used to treat peripheral vessel haemorrhages

* A software device using artificial intelligence algorithms for use in breast screening

* An artificial intelligence-based skin lesion analysis device

Read more here

Medical device post-market reviews

* Post-market review of energy-based devices used for vaginal rejuvenation found there was insufficient clinical evidence to support the therapeutic use and long-term safety of these devices. Source: TGA

* Post-market review of plastic syringes – the review is onging. As part of the review, some ARTG entries have been suspended for a period of 6 months. This allows the sponsor and manufacturer time to address issues identified during the review. Read more here

How to respond to a medical device post‑market review notice from the TGA – the Post Market Review compliance dashboard is updated here.

The AusUDID – Australian Unique Device Identification Database. New posts from the TGA:

* Learn what the AusUDID is

and many more posts about AusUDID can be found here

A list of 153 AI enabled medical devices is available here.

European Union Medical Devices Directives – “The EU MDR transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition.” – read more here.

Additional medical device news can be viewed in the April 2026 edition of TGA Medical Device Resources published on LinkedIn by Gary Burgess, Hill Valley Regulatory Consulting

TGA Laboratories. Yes, the TGA does have its own labs, and the TGA has just published general information here, and:

* What we test, how we test and what we do with our results

* Testing of therapeutic goods

* International affiliations

Vaping

* Notified vape list: a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Contains information for practitioners and pharmacists. Source: TGA

* 30,000 illegal vaping goods seized in south-west Sydney, the estimated street value is $1.8 million. Source: TGA

Botanical Adulterants Prevention Programme (BAPP) and similar articles

In the BAPP LinkedIn posts you will find:

* Ginseng Adulteration – adulteration of Asian, American, and tienchi ginseng with lower-cost Panax materials and ginseng leaf. Published by BAPP here.

* Adulteration in Raw Botanicals – article published here by Canadian Phytopharmaceuticals

For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.

IN THE PRESS

* Three Victorians arrested following seizure of over $2 million worth of steroids and peptides by the ABF and TGA – report in Australian Border Forces News.

* Reported by Dee-Ann Seccombe on LinkedIn – Australian Broadcasting Corporation (ABC)’s Landline program has just covered the threat facing the Tea Tree Oil industryfrom the European Union, interviewing Dee-Ann Seccombe – “The European Union is considering new regulations that could severely restrict the use of Tea Tree Oil in skincare and personal care products”. – refer to ABC on LinkedIn or video of Landline here.

* USA: Dietary Supplement Listing Act Introduced in House of Representatives. Some are supportive, others are not. Reported in Nutraceuticals World.

Foods