Regulatory affairs news

Complementary Medicines and Medical Devices

Sunscreens – improving regulation – see below in Cosmetics and Sunscreens section

Vitamin B6 (pyridoxine, pyridoxal or pyridoxamine) – Are you unknowingly taking too much vitamin B6? this article discusses the need to check the amount of B6 in all the products you are taking. Excess B6 can cause peripheral neuropathy. Source: TGA. (Editor’s note: I find this particularly relevant, as earlier this month I was looking for a magnesium supplement, but I was finding it hard to find one that did not contain B6, as I already take a B complex. One in particular had 50 mg of B6 along with the magnesium but it wasn’t marketed as “Magnesium and B6”, although the B6 was of course disclosed as an active ingredient).

GMP Clearance – updates about the backlog reduction, actual processing times, existing workloads, requesting prioritisation and other key messages for GMP clearance applications, updated 10th March and published here.

Exclusivity period for a new ingredient permitted for use in listed medicines. If you submitted a successful application to have a new ingredient added to the listed of permitted ingredients, you would have been given a two year exclusivity for use in a listed medicine. If you wish to give other sponsors permission to use this ingredient, a new form has been published for this purpose, download it here.

Ingredients permitted in listed medicines: 22 ingredients have had their conditions changed, the list is here.

Advertising complementary medicines on social media. Australia’s peak body for complementary medicines, CMA, has advised that the TGA will be commencing a targeted letter campaign aimed at improving advertising compliance, focussing on products promoted through online and social media channels, including websites, social media posts, testimonials, influencer or affiliate marketing, endorsements, and other digital content, whether published directly by sponsors or via third parties. This information is not on the TGA website. CMA website: https://cmaustralia.org.au/. We have relevant training courses – see above.

Understanding complementary medicine interface issues – an updated guideline from 2016. Published here. (Editor’s note: we believe the TGA’s guidance is faulty, particularly in relation to the food/medicine interface. (TGA guides in italics and editors comments underlined):

In general, a good is considered a therapeutic good if the good:

* is represented to be for therapeutic use (no problem)

* does not have a food standard in the Australia New Zealand Food Standards Code- there are numerous examples of products, including foods, that do not have a standard in the Food Code. That that does not mean they are therapeutic goods.

* does not have a tradition of use as a food in Australia or New Zealand in the form it is presented – this does not mean it is a therapeutic good – it could be a novel food

* or has been determined or declared to be a therapeutic good under provisions in the Act– no problem

In general, a good is considered to not be a therapeutic good if:

* there is a food standard in the Australia New Zealand Food Standards Code – there are food standards for products that can also be complementary medicines

* it has a tradition of use as a food in Australia and New Zealand in the form it is presented– just one example – powdered herbs can be used in cooking and can also be therapeutic goods

* or it has been determined or declared to not be a therapeutic good under provisions in the Act – no problem

The Poisons Standard – no news this newsletter

Public and stakeholder consultations:

* Sunscreens – see below

* GMP – The Pharmaceutical Inspection Co‑operation Scheme (PIC/S) has opened a consultation on proposed revisions to Annex 6 (Manufacture of medicinal gases) and Annex 15 (Qualification and validation). Consultation closes 9th April. More information here.

* TGA is reviewing rules for personalised medical devices to make sure they keep pace with new technology and continue to be used safely. Consultation closes 24th April, more here.

* Proposed changes to medical device conformity assessment procedures. Consultation closes 14th April, read more here.

Medicinal cannabis products – list of unapproved products (5 different categories) supplied in Australia via the Special Access Scheme and Authorised Prescriber scheme. Source: TGA

TGA’s freedom of disclosure (FOI) log – last updated 27th March 2026, is here.

Medicines and medical devices that have been cancelled or suspended by the sponsor  – list updated 24th March, is here

Medicines and medical devices that have been cancelled or suspended, and no longer appear in the ARTG – updated 2nd March, published here.

Listed medicine compliance reports updated 31st March. Summary is here (19 sunscreens and 13 other products) and the list of products is here. Of the 13 “other products”:

* Medicines containing phenylalanine

* Medicines reviewed to check whether they meet stability requirements

* Medicines with non-permitted health claims about: cardiovascular, neurodegenerative, and metabolic diseases, iron deficiency, mycosis, vaginosis, intimate discomfort or regeneration of vaginal microbiota, nicotinamide adenine dinucleotide (NAD, NAD+, NADH) or nicotinamide mononucleotide (NMN), and

* weight loss.

Following the review, 9 of these products have been cancelled from the ARTG and 2 have been recalled.

Compliance activity – Compliance enforcement

* Infringement notices:

TGA has issued infringement notices to three health practitioners for alleged unlawful import of unapproved therapeutic goods:

* Victorian-based nurse – vials of unregistered botulinum toxin, and pre-filled syringes of hyaluronic acid and lidocaine.

* Victorian-based podiatrist – unregistered pre-filled syringes containing hyaluronic acid

* NSW-based medical practitioner – unregistered vials containing glutathione.

The infringement notices, totalling $23,760, have all been paid. Source: TGA

* Approved COVID-19 rapid antigen self-tests included in the ARTG for supply in Australia, updated 12th March, here.

Adverse event notifications: database last updated 7th March, includes medicines and medical devices – read it here.

* You can also learn about the Medical Dictionary for Regulatory Activities (MedDRA) – an international medical terminology used to code, classify and group medicine adverse event reports in the Database of Adverse Event Notifications, supporting consistent safety monitoring and regulatory reporting – here.

Recalls

* Recall coordinators for therapeutic goods – contact details for the state and territory recall coordinators as well as the Australian recall coordinator updated 5th March here.

Product correction

* TRUE METRIX® Blood Glucose Monitoring Systems – this correction updates the instructions provided with the device to clearly explain the actions users should take if an E-5 error code appears, particularly if they are experiencing symptoms of high blood glucose levels. Source: TGA

Shortage of transdermal HRT patches – read more here.

Asherman Syndrome – a uterine condition linked to intrauterine scarring that can affect fertility and menstruation – and risks associated with some medical devices. In some cases, it has been found to develop following intrauterine surgical procedures. Source: TGA

Medical device post-market reviews:

* Information page about safety and performance updates and emerging issues is here.

* The medical device post-market review process is detailed here.

* Post-market review of plastic syringes – here.

* Post-market review of metal-backed patellae – here.

* Guidance on mandatory requirements and ongoing responsibilities for manufacturers and sponsors of medical devices – updated 12th March – published here.

* Advertising software-based medical devices – published 30th March here

Check your product is a medical device that needs to be included in the Australian Register of Therapeutic Goods (ARTG) – guidance here.

Software-based medical device exclusions. Sixteen different TGA web pages are listed here.

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

Vaping

* the list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia, updated 13th March, is here. 

* Vapes: compliance and enforcement – how the TGA approaches and manages compliance, updated 5th March and published here.

Statutory advisory committees, working groups and industry consultation groups – information on a number of different groups and committees updated 18th March here.

Botanical Adulterants Prevention Programme (BAPP) and similar articles

In the BAPP LinkedIn posts you will find:

* Sawdust found in an active ingredient

* The latest on ginseng adulteration

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

IN THE PRESS

* Australian Border Force intercepts 150,000 units of melatonin amid crackdown on unregulated products. The Australian Broadcasting Corporation is reporting on the seizures of melatonin between September and December 2025, and reports that “melatonin users have called for more affordable and accessible alternatives of the sleep hormone.”. In the last edition of this newsletter we reported that tests on imported unregulated melatonin products found that some products contained up to 400% more melatonin than stated.

* Vaping likely to cause cancer, new Australian review of evidence has found nicotine-containing vapes are likely to cause lung and oral cancers. In addition to cancer, researchers say a range of other diseases can be attributable to vaping, and it can no longer be considered “safer than smoking.” Published by The Australian Broadcasting Corporation