current affairs
Issue 251, 3rd October – 31st October 2024
Training news
Introduction to Regulatory Affairs in Australia. One of our first courses, now available on demand as pre-recorded modules on our e-Learning platform. This means you can learn at your own leisure at a 20% lower fee than our live personal tuition delivery. It is ideal for new-comers to the Australian health products industry, offering an introductory overview of the regulation of listed medicines (complementary medicines and primary sunscreens), low risk medical devices, foods and cosmetics. Read more and book the course here.
Pharmacovigilance. Updated to include new resources and content that makes the complex topic of medicine safety approachable and systematic. This course is now presented by Mary Nteris, PhD in Pharmacology. Mary can also act as your qualified person to fulfill your pharmacovigilance obligations. The feedback on the training has been exceptional and you can see Mary’s CV here..
We now have almost 30 regulatory affairs courses, you can view them here and book online here
Regulatory affairs news
Complementary Medicines and Medical Devices:
Nitrosamine impurities – update to acceptable intakes to include harmonisaton with current EU guidelines. This TGA webpage includes useful links.
The South African Health Products Regulatory Authority and the TGA have signed a Memorandum of Understanding which will strengthen collaboration between the two health product regulators and help improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered. Read more here.
Medical devices: Essential Principles. Updated information is here.
Medical devices affected by the closure of the 3G mobile phone network. Not all devices are affected, but the ones that may be affected are listed here. This includes products not regulated by the TGA such as security alarms, smart watches and many others. Very useful information!
Misinformation about excessive DNA in mRNA vaccines. This article addresses many concerns about the manner in which this information was gathered, including selective reporting and method validation, the sample number, the small number and non-accredited laboratories involved. Read the full article here.
How to access unapproved therapeutic goods through the Special Access Scheme or Authorised Prescriber scheme. An explanation and guide to the requirements which commenced of 1st July. Avalable on TGA website.
Consultations
* Australian Medical Device Essential Principles – Part 2: Proposed alignment with the European Regulation. More information has been provided. Closes 13 November. Read more here.
* Consultation on changes to 6 forms and processes, with closing dates ranging from 8th November 2024 up until 31st July 2029. See the full list here.
TGA GMP Forum. 19th – 20th November in Melbourne. Details here
Compliance action
None to report this month except for the ones listed under “Vaping”.
Safety alerts
* Ziyinzhuangyang tablets purchased online contain the undeclared substance sildenafil. Source: TGA
* Imported counterfeit ivermectin products have been found to contain less than the stated amount of 12 mg of active ingredient. Source: TGA
* Imported African Vigorous Max Strength contains the undeclared substance sildenafil. Source: TGA
* NSW Health has published a warning about MDMA tablets being sold containing a higher dose then normal of MDMA and some also have added dipentylone, a synthetic cathinone with stimulant effect. Source: NSW Health
Vaping
* Enhanced standards for therapeutic vapes. This includes vaping substances, vaping substance accessories, vaping devices and vaping device accessories. From 1 July 2025, only those vapes that meet the updated standards can be lawfully supplied in Australia. Read about the key changes here.
* From 1st October patients 18 years or over can purchase therapeutic vapes from participating pharmacies without a prescription, but a consultation with a pharmacist is required. There are now two lawful pathways for accessing therapeutic vapes – the pharmacist only model and the prescription model. More information on this TGA webpage.
* $8 million worth of illicit vapes seized in Box Hill, Victoria in an operation involving the TGA, Victorian Department of Health and Victoria Police. Source: TGA
* Retailer in Bundaberg fined $18,780 for unlawful possession of a commercial quantity of vapes at their retail store. Source: TGA
* Eight people arrested and charged for directing and assisting an organised crime syndicate. Victoria Police seized 600,000 tobacco sticks, tobacco products and vapes and other assets alleged to be the proceeds of crime including luxury cars. Source: TGA
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 more details here
Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories.
* Cordyceps aldulteration. Because of the great value of cordyceps (Ophiocordyceps sinensis, syn. Cordyceps sinensis), its rarity in the wild, and the difficulty of cultivating it, adulteration and substitution frequently occurs. Bulletin available here.
To access freely available botanical and technical resources from BAPP, click here
World first ambulances introduced in NSW. Specially designed vehicles based on Mercedes-Benz Unimog vehicles can drive through flood waters up to 1.2 metres and operate around fire grounds. They are fully operational ambulances. Read more: NSW Health.
New Zealand
New legislation. In a recent press NZ Health stated: On 30 September, Cabinet agreed to repeal and replace the Medicines Act 1981 with a new Medical Products Bill.
The Bill will provide modern, risk-proportionate regulation of medicines and medical devices (‘medical products’). It will support improved health outcomes for all New Zealanders by enabling timely access to safe, high quality, and effective medical products. The Bill will support patients, practitioners and industry.
In committing to develop a Medical Products Bill, Cabinet agreed the legislation should be harmonised with international good practice and support innovation, competition, economic growth, and exports in a way that maintains New Zealand’s reputation as a producer of high-quality products.
They also state: On 30 September, Cabinet also agreed that natural health products will be regulated under a standalone bill, to be developed following engagement with the natural health products sector. The Ministry will work with Minsters and the Ministry for Primary Industries to agree the timing and manner of stakeholder engagement.
Work on a new natural health products bill will not commence until after we have engaged with stakeholders; and no decisions have been taken on the scope or approach to be adopted in the bill.
Information is available:
* Cabinet material: Modernising the Regulation of Medicines and Medical Devices
* Regulatory Impact Statements: Medicines regulation and Product and activity controls for medical devices
Webinar on the Medical Products Bill. The New Zealand Ministry of Health is running a webinar on the proposed new bill on the 7th November at 12 pm New Zealand time. You can access the webinar via this link.
Foods:
FSANZ asks for feedback on their performance. Survey is on their website here and closes 15th November.
New applications and proposals
* A1315 – Chitosan and (1,3)-beta-glucans from white button mushrooms (Agaricus bisporus) as a food additive in food and beverage products. FSANZ
* Food derived from short-stature corn line MON94804, genetically modified FSANZ
Approvals
* A1247 D-allulose as a novel food – D-allulose manufactured by an enzymatic conversion of fructose to D-allulose using Microbacterium foliorum SYG27B-MF containing allulose-3-epimerase as a sweetener FSANZ.
Recalls
* Candy People is conducting a recall of Gott & Blandat Original due to undeclared allergen – wheat. Source: NSW Food Authority.
* Y Y INT’L is conducting a recall of Gold Plum Chinkiang Vinegar due to the presence of an undeclared allergen (sulphites). Source: NSW Food Authority.
* Bharat Foods – Rajah’s Rasoi Gur Rewadi – presence of undeclared allergen, sesame seed FSANZ
* Trans Oriental Import & Export – ABC Kecap Manis, ABC Kecap Asin, Hati Angsa Kecap Kental Manis, Bango Kecap Manis – undeclared allergens gluten sulphites, soy and wheat in many of these products FSANZ
* Nocelle Foods – Nature’s Delight – Ranger Mix – undeclared allergen cashews FSANZ
Food allergen rules. A comprehensive web page for food businesses, explaining how to follow the rules set out in the Food Standards Code. Published by NSW Food Authority.
More food news forwarded by Gary Kennedy of Correct Food Systems
* Update on “no added sugars” – based on Proposal P1063 – Added sugar(s) claims – the proposal was to remove the term ‘sugars*’ from the Code as that term is now redundant as a result of the amendments made by Proposal P1062 – Defining added sugars for claims). The transition period is the period of time that commences on 13 December 2023 and ends 13 December 2027.
* Australian Drinking Water Guidelines.
The National Health and Medical Research Council has released a public consultation for the Australian Drinking Water Guidelines on Draft Guidance for Per- and Polyfluoroalkyl Substances (PFAS). The NHMRC has drafted an update of the PFAS Fact Sheet within the Guidelines which includes revised and newly established health-based guideline values. The draft fact sheet is supported by a NHMRC Statement on PFAS in drinking water, which provides a summary of the findings which informed the update.
The PFAS reviewed as part of this update PFOA, PFOS, PFHxS, PFBS and GenX chemicals and all include a reduction in the guideline limits from the current limits. PFOA limit reduced from 560 ng/L to 200 ng/L; PFOS and FHxS reduced from the sum of PFOS and PFHxS = 70 ng/L to PFOS 4ng/L and PFHxS 30 ng/L;; PFBS no current guidelines but new limit to be 1000 ng/L; and no guidelines are proposed for GenX Chemicals.
In the press:
Study finds surprising detail in food for infants, toddlers. “Monash University examined ready-made pouches and boxes sold in Australian supermarkets and found less than a quarter met all nutrient requirements outlined by the World Health Organisation”. News.com.au
New Zealand food safety bulletins published each fortnight here.
New Zealand Food recalls: in the last month there have been nine recalls:
* Hellers brand Shaved Roast Chicken – undeclared allergen – soy. NZMPI
* Nishin brand Seasoned Seaweed Salad – undeclared allergens gluten and wheat NZMPI
* My Food Bag brand Middle Eastern Spice Blend undeclared allergen gluten NZMPI
* My Food Bag brand All The Flavour Dukkah – undeclared allergen peanut NZMPI
* Gilmours brand Jalapeno Flavoured Corn Chips – undeclared allergen soy NZMPI
* Farro Kitchen brand Pulled Lamb Shank Ragu – may contain foreign matter, glass NZMPI
* ABC brand Sweet Soy Sauce Kecap Manis – undeclared allergens gluten, soy, sulphites & wheat NZMPI
* Huaseed brand Dried Kelp Slices – an elevated level of arsenic (inorganic) NZMPI
* Wako Shokai, Yamanaka Foods and Ichbiki brand Seaweed products – elevated level of arsenic (inorganic) NZMPI
Cosmetics and TGA listed sunscreens:
Warning to clients of Fresh Cosmetic Clinic to get tested for blood borne viruses due to infection control breaches in the Clinic. This applies to any patients who have had injections of procedures such as breast implants, facial or nasal line carving. Patients should be tested for hepatitis B, hepatitis C and HIV. Source: NSW Health.
Submit your annual declaration for 2023-2024 – due by 30 November 2024. Every industrial chemical introducer (importer or manufacturer) – includes cosmetics – must make an annual declaration. Some chemicals are exempt. Read more here.
A new self-guided tool is available for soap importers and manufacturers. Do you need to register with AICIS? This decision tool will guide you.
Consultation on proposed changes to the Industrial Chemicals Categorisation Guidelines that will come into force in September 2025. Changes mainly relate to list of chemicals with high hazards for categorisation. Feedback required by 5tth December. AICIS.
Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply) :
as at 30th October: three chemicals added, CAS 2155803-51-1, CAS 2231240-99-4 and CAS 1196069-20-1.AICIS.
Variation of Inventory listing following revocation of CBI approval – none this month
Variation to inventory listing after evaluation– none this month
New chemical assessment statements as at 8th October: three published and listed here. their functions are Component of asphalt (bitumen) emulsion, Component of fire resistant foam adhesive, and Flotation agent in metal extraction.
Commercial evaluation authorisations allow a business to import or manufacture a chemical for commercial evaluation purposes. Nine listed here, none are relevant to cosmetics! All except one are “Tracers in hydraulic fracturing in the oil and gas industry”
Chemicals added to the inventory following issue of assessment certificate as at 18th October: one chemical, CAS 66094-79-9 AICIS
Additional cosmetic news supplied by Rita Sellars of pH Factor
Azelaic acid is a multifunctional ingredient in skincare formulations, with properties which can be used to address various skin concerns, especially in gentle and effective formulations targeting sensitive and acne-prone skin.
Changes effective 1st October – this ingredient is now listed in the Poisons Standard – the Standard for the Uniform Scheduling of Medicines and Poisons – in Schedules 2 and 4.
Schedule 2 products are available from a pharmacy or, where a pharmacy service is not available, from a licensed person. Schedule 2 products are labelled with ‘Pharmacy Medicine’.
Schedule 4 chemicals are available from a pharmacist on a prescription. Schedule 4 chemicals are labelled with ‘Prescription Only Medicine’.
Currently, the TGA has addressed the scheduling for Azelaic Acid and its use, particularly for cosmetic and therapeutic applications.
It has a NEW ENTRY, Schedule 5, which refers to substances that pose low to moderate risk of harm to human health and safety if not handled properly. These substances require cautionary labelling and packaging to ensure that the risks are mitigated, but they are generally considered safe when used correctly under specified conditions.
As of 1st October, any azelaic acid product, including dermal cosmetic or therapeutic goods, would need to have “avoid contact with skin” on the label. These include cosmetic preparations containing no more than 10% azelaic acid. The TGA is maintaining tight controls due to concerns about eye and skin irritation and ensuring that any products sold outside pharmacies are labelled appropriately for safety. This scheduling is part of a wider approach to ensure that products with potential health risks are appropriately regulated. Read the reasons for the final decision here.
ACCC and similar:
The ACCC has commenced separate proceedings in the Federal Court against Woolworths Group and Coles Supermarkets for allegedly breaching the Australian Consumer Law by misleading consumers through discount pricing claims on hundreds of common supermarket products. It is alleged that prices were raised for a short period before being advertised as being lowered. ACCC
“Breaking down the latest from the FTC on endorsements and consumer reviews” – an article prepared by Lauren Aronson from US law firm Amin Wasserman Gurnani can be read here. (Note: Lauren presents our training course on US advertising regulations, read about it and book the course here.)
Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics dietary supplements.
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