Changes to the regulation of vitamin B6.

* Oral preparations containing 50 mg or less per recommended daily dose (MRDD) will continue to be available for general retail sale.

* Preparations containing more than 50 mg but not more than 200 mg per MRDD will be available over the counter with the advice of a pharmacist

* Preparations containing more than 200 mg per MRDD will continue to require a prescription.

Source: TGA

* Notice of final decision to amend (or not amend) the current Poisons Standard in relation to pyridoxine, pyridoxal or pyridoxamine (vitamin B6) – reasons for the final decision was ” reported severe, sometimes permanent, health effects from vitamin B6 toxicity including peripheral neuropathy, nerve damage, muscle weakness”. Read the report here.

(Editor’s note: a family member suffered acute peripheral neuropathy after a medical doctor advised him to take 325 mg of B6 daily)

Nitrosamine risk in listed medicines. Information for sponsors and manufacturers on assessing the risk of potential nitrosamine contamination in listed medicines. this is an update to previous guidelines for listed medicines. The TGA states “We recognise that complex ingredients with variable composition – such as botanicals and other naturally derived medicinal substances – are not covered by this advice.” but is does apply to many other ingredients in complementary medicines. This guideline summarises possible sources of nitrosamine contamination during manufacture.

AUST numbers on medicine labels. All medicines included in the Australian Register of Therapeutic Goods (ARTG) must include the relevant AUST number (either AUST R, AUST L or AUST L(A) number) on the label. If a medicine does not have an AUST number on the label then it is being supplied illegally unless access to the medicine has been approved. This page lists medicines to which the TGA has given consent to be imported or supplied without the AUST number on the label.

GMP clearance Sponsor Information Dashboard contains updates about the backlog reduction, actual processing times, existing workloads, requesting prioritisation and other key messages for GMP clearance applications. Last updated 7 November.

Advertising therapeutic goods – summary page updated 12 November includes various topics, here.

(Information about our course on TGA advertising regulations is here. Our course is conducted by Leanne McCauley who spent 9 years working in the TGA advertising unit). 

Social media

* Understanding social media advertising rules. Updated on 12 November, these apply to influencers, talent management agencies and social media account holders. Source: TGA

* Advertising therapeutic goods on social media. Updated 5 November to help advertisers, is published here

* Updated social media advertising guidance to support improved compliance – this page summarises the above two items.

(These updates triggered a revision of our popular course Advertising and Social Media in Australia and New Zealand, which also covers foods and cosmetics – see details at the top of this newsletter)

Women’s Health Products Working Group meeting – this communique summarises some very important issues that were discussed.

TGA’s freedom of disclosure (FOI) log – last updated 26 November, is here.

Medicines and medical devices that have been cancelled or suspended – list updated 20 November 2025 Source: TGA

Unapproved therapeutic goods.

* SAS: Special Access Scheme for unapproved therapeutic goods. Updated 11 November. For individual patients, guideline here. For multiple patients, read here.

* Health practitioners can access unapproved therapeutic goods in certain circumstances. Who can apply, what you can access and what to do before you apply – summarised here.

* Becoming an authorised prescriber for unapproved therapeutic goods – Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of ‘unapproved’ therapeutic goods. Very comprehensive guidelines are published here.

Compliance activity

* Nothing to report!

Accessing medicinal cannabis for a patient. Various pathways are available, and are discussed in detail here.

Guidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements was updated on 7 November and includes test methods, and specific tests for hospital grade disinfectants and household / commercial grade disinfectants. Source: TGA

Vaping

* Prescribing and dispensing of prescription only therapeutic vaping goods to patients under 18 years of age. Information to assist prescribers (medical and nurse practitioners) and pharmacists. Summary table details the different regulations in 8 different states and territories. Published here.

* Notified vape list: a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can legally be prescribed. A list of 918 products. Also on the same page, a list of 1,461 products that have been either been withdrawn (the sponsor has voluntarily withdrawn the notice), or ceased (the TGA has determined that the good should no longer be supplied). Published here.

* A form that allows sponsors of notified therapeutic vaping goods, which includes therapeutic vaping kits, to provide information to the TGA is available here.

* Information for pharmacists – requirements for dispensing and supplying vapes, including clinical resources, storing, dispensing and supply, compounding, reporting, and a lot more! Read it here.

The Advisory Committee on Medical Devices: updates from previous meeting summarised here.

Updated: Guidance on how medical devices must comply with the Essential Principles of safety and performance. 15 Principles are listed – summary is here.

Companion diagnostics (CDx) approved for supply in Australia. A CDx is an in-vitro diagnostic (IVD) medical device that provides information essential for the safe and effective use of a corresponding medicine or biological. Updated 13 November, 44 entries in summary table here.

EU MDR Transition web publication service is a platform for sponsors to provide market notifications to health care providers and consumers for devices going through low-risk changes.  6 criteria will need to be met to qualify for this streamlined market notification process. Source: TGA

Medical device reforms: Consumer Working Group meeting statement arising from 22 August meeting. Includes the UDI database, nicotine and cannabis vaping devices, mandatory hospital reporting of device adverse events and more. Source: TGA

COVID-19 rapid antigen self-tests (home use) approved in Australia – updated list of 122 products is published here.

Windows 10 end of support: Potential impact on medical devices – information for consumers, manufacturers and sponsors published here.

The safety of Australia’s vaccines. A joint statement from the Head of the TGA and Australia’s Chief Medical Officer, read more here.

Public and stakeholder consultation:

Proposed changes to the regulation of medicinal maggots. Reforms aim to ensure the regulation of medicinal maggots is fit-for-purpose, support manufacturers to maintain the uninterrupted supply of medicinal maggots, and considers patients’ need to access while ensuring quality and safety of treatments. Deadline is 10 December, summary is here, and the consultation document is here.

TGA corporate structure. This new web page summarises the divisions and the many branches within them in the TGA.
* Regulatory Legal Services Division
* Medicines Regulation Division
* Medical Devices and Product Quality Division
* Regulatory Practice and Support Division

TGA contact details – email, phone, fax, post, social media channels – have been updated.

Botanical Adulterants Prevention Programme (BAPP): Quality issues persist in St John’s Wort supplements sold online. Article on LinkedIn

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

IN THE PRESS

* Vitamins to be removed from shelves over poisoning concerns. Supplements containing high levels of vitamin B6 will be removed from general sale after the medicines watchdog received more than 100 reports from people suffering severe and sometimes permanent health effects while taking the products. Source: Sydney Morning Herald … and also TGA says some vitamin B6 to be removed, prescriptions needed after toxicity cases Sydney Morning Herald

Foods