Update to ingredients permitted in listed medicines. Listed medicines do not only include most complementary medicines, but also primary sunscreens and some other medicines. Updated 16 October. Read about the changes here – 5 ingredients added and 5 have changes. See the updated list of permitted ingredients here – sorted alphabetically into volumes.

Consultations: 

* TGA seeking feedback on whether the current exclusion for certain digital mental health tools (DMHTs) DMHTs should be kept, removed or modified. Digital mental health tools (DMHTs) include apps, websites and chatbots that provide assessment, therapy or self-management strategies for mental health conditions. Closes 7 December. Read more here

* Vitamin B6 – proposed changes to the list of ingredients permitted in listed complementary medicines containing pyridoxine hydrochloride, pyridoxal 5-phosphate and pyridoxal 5-phosphate monohydrate. Four label statements are proposed. Closes 25 November. Read more here

* Proposed changes to permissible ingredient list: 1. Myristica fragrans use during pregnancy and lactation, and 2. Requirements relating to amygdalin and hydrocyanic acid. Read an overview here and the full consultation paper is here. Closes 14 December.

Advisory Committee on Complementary Medicines – meeting statement from 30 July meeting. Topics discussed included Withania somnifera and Andrographis paniculata. Read the statement here.

Compositional guidelines for ingredients permitted in listed medicines

* Bacillus coagulans strain ATCC PTA-126829 – read it here.

* Gamma glutamylcysteine (γ-GC) is a dipeptide of L‑cysteine and L-glutamic acid linked through the gamma (γ)‑carboxyl group of glutamic acid. Published here.

* Hydrocarbons, C6-C20, polymers, hydrogenated – is here

* Magnesium L-threonate monohydrate is a magnesium salt of L‑threonic acid. Guideline is here.

* Mitoquinol mesilate – here

* Styrene/isoprene/styrene block copolymer is here

TGA licensed manufacturers

* Decisions relating to the granting of licences updated 12 October here.

AUST numbers on medicine labels – updated guidance as at 8 October, here.

TGA’s freedom of disclosure (FOI) log – last updated 28 October, is here.

Clinical trials

* regulations are being updated – see here. and also here for info in the National One Stop Shop for clinical trials

* Human Research Ethics Committee (HREC) and TGA Clinical Trials Discussion Forum held in October – presentations summarised here

* Guidance about how Clinical Decision Support System (CDSS) software is regulated. Find out when this software is exempt from inclusion in the Australian Register of Therapeutic Goods. More here

Medicines and medical devices that have been cancelled at the request of the sponsor: updated 30 October, published here.

Compliance activity – Compliance enforcement

* Infringement notices: a list of infringement notices issued in response to breaches, updated 6 October published on this webpage

* The Federal Court has ordered CDA Clinics and Dr Benjamin Jansen to pay $6.5 millionin civil penalties for the unlawful advertising of medicinal cannabis for the treatment of cancer, mental illnesses, autoimmune conditions, fibromyalgia, chronic pain, seizures, meningitis and autism. Read more here.

* TGA, Queensland Health and the Queensland Police Service targeted the alleged unlawful storage and distribution of illicit vaping goods, illicit tobacco and unapproved nicotine products. More here.

* More than $126,000 in infringement notices for unlawful importation and advertising of prescription-only medicines issued to 2 companies and 5 individuals – the infringement notices have all been paid. Details here.

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Advertising Compliance Investigations Outcome – published here

Listed medicine compliance report – no updates since last newsletter (30 Sep update)

Instruments – a large number of “instruments” affect many products and there is a summary of them all here

Court actions resulting in criminal prosecutions – updated 30 October here.

Recalls

* Recall coordinators – state, territory and national recall coordinators revised contact details are here.

* Andrographis: list of products recalled due to risk of severe allergic reaction – updated 30 October – over 40 products listed here.

Importing therapeutic goods

* do you want to import a product that does not comply with certain standards? You may be able to apply for consent. Read how here.

* Search consents to import, supply or export therapeutic goods that do not comply with standards – here

Updated guidance: regulatory requirements for supplying therapeutic goods that contain, or are produced from, human plasma – find it here

Vaping: Notified vape list, goods for smoking cessation or nicotine dependence that can legally be supplied, updated 2nd October here.

Unapproved nicotine gum products – TGA warns that nicotine is highly addictive and can be harmful to health, and should be kept out of the reach of children. Read more here.

Submitting data in  Electronic Common Technical Document (eCTD) format – updated guide here – How to submit applications, reports and documentation updated guide here 

Medical devices

Digital scribes

* Outcome of the review of digital scribes supplied in Australia, summary here full documents here.

* When are digital scribes regulated as medical devices. Digital scribes (also referred to as artificial intelligence (AI) scribes, ambient scribes or ambient voice technology) are increasingly used in clinical settings to capture conversations between patients and healthcare practitioners. These tools generate clinical notes, summaries, letters or other outputs, which may be added to patient records. Information here.

Updated form for approval of a new Technical Master File (TMF), an annual update to an approved TMF, or a significant update to an approved TMF. is available here

Updated Guideline: Preparing and maintaining a Technical Master File (TMF) is available here

Review of the exclusion for certain digital mental health tools – in progress. Read the findings as at 19 October here.

Two webinars on digital mental health tools are being held on the 10 November and 18 November. Details here.

UDI for healthcare – how healthcare organisations can prepare for and adopt UDI. Updated 29 October.

UDI news and updates as of 29 October, here.

Latest enhancements and fixes to the Australian UDI Database are here

Overview for healthcare – Learn how to use the Australian Unique Device Identification Database (AusUDID) and understand the information shown in the database. Updated 28 October, here.

EU MDR transition publication service – updated 26 October information here.

Dealing with the TGA – updating or adding an organisation administrator – new form is available here.

Botanical Adulterants Prevention Programme (BAPP) and similar articles supplied by Michael D. Levin of Health Business Strategies LLC 

* Lemon balm (Melissa officinalis, Lamiaceae) is a popular medicinal herb commonly consumed as a tea for its calming effects and to promote sleep. Nine commercial samples were analysed but four were found to be lemon verbena (Aloysia citrodora)  Read more here

* Comprehensive high-performance thin-layer chromatography analysis of Monteverdia ilicifolia leaf and its adulterants – published here.

* BAPP webinar – 𝐌𝐞𝐭𝐚𝐛𝐨𝐥𝐨𝐦𝐢𝐜 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡 𝐭𝐨 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐂𝐨𝐧𝐭𝐫𝐨𝐥. register here

* Saw Palmetto common adulterants – by Kerry Hughes, on Linkedin here.

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

IN THE PRESS

* Coroner recommends TGA review peptide restrictions after Australian actor’s death. ”

He collapsed and suffered a cardiac arrest after injecting the products, which a doctor had prescribed to him. In findings delivered on Wednesday, Mr Ryan said Norton “had been taking amounts of the medication in excess of the dose prescribed by his medical practitioner”. Published on abc.net.au

* Why are unapproved peptides still allowed to be prescribed by doctors? Also on abc.net.au

* and ‘Enormous surge’ in peptide use forces needle and syringe programs to restrict safe injecting resources. abc.net.au

Foods