Changes to regulation of medical devices. These changes affect software-based medical devices, prescription spectacle lenses, medical devices containing microbial, recombinant, or animal substances, and medical device application audit requirements. Read more here

Exempt medical devices: do not need to be included in the ARTG, but still need to comply with other regulatory requirements. These include adverse advent reporting, recalls, compliance with the advertising code, conformity assessment procedures, and essential principles. This TGA webpage contains more details plus links to the list of exempt medical devices and other issues just mentioned.

Prescription lenses supplied only for refractive correction are now exempt from the requirement for inclusion in the Australia Register of Therapeutic Goods, whether they are mounted in frames or unmounted. The exemption does not apply to all types of prescription lenses. Source: TGA

Changes to GMP inspections. TGA is introducing temporary new arrangements for GMP inspections of domestic and overseas manufacturers. These inspections will be called ‘surveillance inspections.’ which are full-scope, reduced-duration re-inspections of manufacturers. This means that the inspection will cover all aspects of the manufacturers’ Pharmaceutical Quality System and operations; however, the inspection duration can be reduced by approximately 50% of the typical inspection time. Also, the expiry of existing GMP certificates for TGA licensed sites has been extended from 3 to 4 years. Source:TGA

Compositional guidelines for ingredients in listed medicines that do not have a monograph in an established pharmacopoeia are updated from time to time. Guidelines updated in June 2024 include DHA-rich oil derived from microalgae Schizochytrium sp; Bacillus subtilis strain NRRL B-67989; and D-glucose, polymer with xylitol. Access revised guidelines via this TGA webpage

TGA GMP Forum. 19th – 20th November in Melbourne. Details here

Risk management. A TGA presentation delivered at the ARCS Annual Conference is available here.

How to request the TGA to provide certificates of GMP compliance for Australian manfacturers – go here to read more and download either the MS Word or PDF version.

Compliance action

* Infringement notices totalling $319,260 have been issued to 4 businesses and 3 individuals for alleged unlawful advertising of prescription-only medicines for weight loss on their websites. Medicines were advertised for indications not approved for the products, and other breaches of the advertising code included stating that the products are safe. Businesses included Advert Digital, Eveadam Health, Chronic Therapy and Reda Compounding Chemist.  Source: TGA
* News Life Media has been issued with infringement notices for $56,340 for alleged unlawful advertising of medicinal cannabis on their popular lifestyle websiteBody+Soul. Source: TGA

* TGA has accepted a court enforceable undertaking from 2San in relation to unlawful import and supply of unregistered therapeutic goods, being bacterial vaginosis tests and pregnancy test kits not included in the Australian Register of Therapeutic Goods. Source: TGA

* TGA has issued 35 infringement notices totalling $627,252 to 6 businesses and 2 individuals for the alleged unlawful advertising of medicinal cannabis on their websites and social media platforms. Companies include Botanic Wellness, Grandiosa Imports, Releaf Group, NectarTek Australia, Tukken, Cymra Life Sciences and two individuals. More details here. 

Vaping
* The “business surrender scheme” has been set up to ” … allow businesses holding vaping goods that can no longer be supplied in Australia to divest themselves of these products without committing a supply or possession offence.” Businesses must notify the GA before 1st September 2024. Details here
* The new vaping laws commenced on 1st July. Some of the changes: non-pharmacy retailers, such as tobacconists, vape shops and convenience stores, cannot sell any type of vape; therapeutic vapes will continue to be available from pharmacies where clinically appropriate; to purchase vapes containing nicotine or a zero-nicotine substance, everyone will need a prescription from a medical or nurse practitioner; flavours for therapeutic vapes are restricted to mint, menthol and tobacco; anyone involved in transporting, storing or handling vapes must comply with strict requirements; the advertising or promotion of vapes is generally prohibited. More details here.

* TGA Vaping hub is here

Safety alerts. 

* Medicines containg Andrographis paniculata have the potential to cause severe allergic reactions including anaphylaxis.  Andrographis is a herbal ingredient permitted for use in low-risk medicines in Australia. Approximately 100 medicines listed in the Australian Register of Therapeutic Goods (ARTG) contain andrographis. It is commonly used in Indian and Chinese medicine. More details here. (We have a course on Pharmacovigilance . .agenda here)

* Serious side effects in infants given compounded wind and colic products containing Atropa belladonna (belladonna) have been reported. Symptoms in an infant that include dry mouth and skin, dilated pupils, inability to pass urine, floppiness and poor feeding. Source: TGA

* TGA has tested Robust Extreme Capsules imported from overseas and found they contain the undeclared substance o-propyl vardenafil, an analogue of vardenafil. Vardenafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates. Source: TGA

Mandatory new safety and information strandards for all infant sleep products including products such as rockers, bassinets, household cots and folding cotsRead safety standard here and information standard here. Read more details on the Product Safety Australia website

Consultations 

* The TGA is seeking public comment on proposed models to estimate sunscreen use (exposure) by Australians which will be used to calculate the maximum safe concentration of sunscreen ingredients. Submissions close 13th August 2024.Three options proposed on this webpage which includes links to the consultation paper and an online survey.

* Instructions for Disinfectant Testing. TGA is seeking feedback on a revised version of the guidance document. Submisions due by 16th August. Details here.

* Reforming Australia’s Therapeutic Goods Testing Regulations. Proposal includes strengthening and modernising the legislative framework for the examination, testing and analysis of therapeutic goods. Submissions close 18th August 2024. Source: TGA

* TGA seeking feedback on reforms to regulations of some “boundary products”.Consultation closes 6th August. Information here and guidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices is here.

National Symposium on Australian Traditional Medicine. This will be held at the NICM Research Institute, Western Sydney University, on 11th-12th November 2024. Full details at westernsydney.edu.au

Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories.

* Rose – Rosa x damascena – essential oil. BAPP bulletin discusses composition, quality, known adulterants and methods of detection. Published in HerbalGram.

* Education Combined with Enforcement Reduces Lead-Contaminated Turmeric from 47% to 0% in Specific Markets in Bangladesh and India. BAPP article published in HerbalGram

* Substitution of Boswellia serrata extracts with citric acid in bulk shipments originating in China. BAPP article published in HerbalGram

* SupplySide recommends exhibitors and attendees adopt Botanical Adulterants Prevention Program to address adulteration in the supply chain. Published in Natural Products Insider

* Adultertation of Aleurites moluccanus (candlenut) and Bertholletia excelsa (Brazil nut) with toxic nuts and seeds from Cascabela thevetia, commonly known as yellow oleander or lucky nut. Source: Taylor and Francis online

* Laboratory guidance document – Actaea racemosa, – black cohosh – from BAPP and published in HerbalGram

* Which botanicals and fungi fail identity tests most often? Alkemist Labs share 20 ingredints that require extra scrutiny. Published in Nutraceuticals world

To access freely available botanical and technical resources from BAPP,  click here

New Zealand news supplied by Michelle Cubitt of Smart Regulatory Solutions

For dietary supplements, the Therapeutic Products Act Repeal Bill has had its first reading in Parliament. Submissions are open until 29 Jul 2024. The bill will go through as the current government has a majority and it was in the coalition agreements that this repeal happens. There is currently no clear indication of what will replace the Act long term and the status quo of the Dietary Supplement Regulations 1985 administered under the Food Act 2014 remains in effect for now. 

More information on NZ Ministry of Health website here.

In the press:

* “Death and Dozens of Illnesses Possibly Associated with Mushroom Candies”.
Prophet Premium Blends recalled Diamond Shruumz products which contained muscimol, a chemical that can lead to illness and death. FDA isinveartiating/ Published in Nutraceuticals World

* “Mushroom gummies recalled Australia-wide after customers hospitalised with ‘disturbing hallucinations’” Published in The Guardian Australia

* “TGA to review warnings after father’s supplement death”. Possibly due to andrographis present in a product called ArmaForce. Published in Sydney Morning Herald.

* “Major Australian pharmacies revolt over new vape laws”. According to this article, many pharmacists are opposed to the new bill which requires vapes to be sold without prescription through pharmacy, as “community pharmacists do not want to supply this potentially harmful, highly addictive product without a prescription.” Source: News.com.au

* Articles published on abc.net.au: “Vape shop owners brace for the end to their businesses, and an uncertain future“; Vapers will be pushed into black market by vape sales ban, crime experts warn“; “The Coalition could have sat back and waited to watch the vaping ban unfurl, but instead, they’ve chosen option two: INHALE“; “As Australia cracks down on vaping, there are concerns that without support some young people could turn to cigarettes“; “Government waters down vaping ban to win support of Greens“;

* And from the Guardian: “Newsroom edition: was Labor right to compromise on banning vapes?” – Full Story podcast

Foods: