Issue 258, 2nd May – 6th June 2025
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Training news
Courses that have recently been updated:
1.12. Compliance Obligations for Listed Complementary Medicines
1.15. Pharmacovigilance obligations (includes New Zealand requirements)
1.17. Advertising medicines and medical devices
3.01. NZ Cosmetic Labelling and Claims (also available as pre-recorded)
Recently added courses relevant to Australian regulations:
1.41. Medical Device Regulation Fundamentals
1.42. Medical Device Classification
1.43. Interacting with the TGA for Medical Devices
And six pre-recorded courses on USA regulations.
View the agenda for all 40 courses and book online here
Regulatory affairs news
Complementary Medicines and Medical Devices
Understanding complementary medicines. A TGA information page about complementary medicines including traditional medicines, herbs and nutritional products. This website also includes a video.
Australia is adopting international scientific guidelines. 19 guidelines have adopted. The TGA has published the list here and this web page includes a link to each guideline.
Medical devices – Unique Device Identification (UDI) regulations came into effect 24 March 2025. Read more here. The TGAS is hosting a webinar on this topic on 11th June. Read more and register to attend here.
IVD medical device classifications, principles and definitions. TGA is seeking feedback on proposed changes. Read more here.
Good Clinical Practice (GCP) inspection activities 2023 – 2024. This link takes you to a TGA presentation covering key areas of compliance and non-compliance.
Assessed listed or registered complementary medicines – updated information about using the “TGA assessed” symbol on a label – available here.
TGA advisory committees: vacancies exist for 7 committees, including complementary medicines and medical devices. Applications must be received by 11:30 pm, Tuesday 10th June. Read more and see how to apply here.
GMP clearance of overseas manufacturers. There has been a backlog of manufacturer clearances to be processed. Read what the TGA is doing about this:
* Backlog reduction strategy commencing 1 July 2025. Includes automatic extension of existing Mutual Recognition Agreement and non-sterile Active Pharmaceutical Ingredient CV GMP clearances due to expire between 1 July 2025 and 30 June 2027; abbreviated evaluation of manufacturing sites performing certain lower risk activities; and ending GMP clearance regulatory flexibilities introduced during COVID-19 pandemic, specifically the GMP Clearance Questionnaire. More details are here.
* Updated GMP clearance information. Includes Health Canada agreement, and adoption of Annex 16 of the PIC/S Guide to GMP. Details on TGA site here.
Has your doctor prescribed you an ‘unapproved therapeutic good’? Under certain circumstances a health practitioner may prescribe an unapproved therapeutic product. Questions a patient should ask include:
* Why have you selected this treatment, and have you considered all TGA-approved options?
* What are the risks and benefits in using this product?
* How much will the product cost?
* Where can I get it / do I have to buy it online or overseas?
Read more here.
Poisons standard:
* Proposed amendments – consultation period closes 13th June.
* Final decisions published 9th May published here
Recalls – now called “Market actions”
What do I need to do if my medicine or medical device is recalled? This new TGA guide explains the four different types of “market actions”:
* A recall – you need to return or dispose of the product.
* A product alert – you need to be aware of a problem or a concern with the use of a product.
* A product correction – there is a problem with the product that needs to be corrected or fixed.
* A quarantine – this means you should avoid using the product altogether, until told otherwise.
Information on the above is on TGA website here.
* Recall: Weleda Baby Teething Powder following a complaint that a fragment of glass was found in one bottle of this product. Source: TGA:
* Recall: Felton Grimwade & Bosisto’s Pty Ltd is recalling all batches of Euky Bear Warm Steam Vaporiser, Model number EBSV2013 due to a quality problem whereby the enclosed heating element can overheat. Source: TGA
* Recall: Brauer Natural Medicine – Baby & Child Teething Gel – due to the potential for a small plastic fragment from the tube rim being present in the gel. Source: TGA
* Product correction: some K Care Seat Walkers were supplied without a complete user manual. More information and a link to download the manual on TGA website
* Updated information page: Database of Recalls, Product Alerts and Product Corrections – Questions and answers: is available here
Social media influencers – a new guide to responsible promotion of health products. Topics include:
* Don’t advertise prescription medicines.
* Don’t advertise therapeutic goods that aren’t entered on the ARTG
* Don’t make false or misleading claims
* Don’t imply that a product has been endorsed by the government or the TGA
* Be careful of hashtags and links
* Don’t make paid testimonials
* Comments are your responsibility
Read more here
Compliance action
* Court proceedings commenced in the Federal Court of Australia against Philips Electronics Australia Limited (PEAL) for the alleged commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements. Source: TGA
Safety alerts
Diabetes and weight loss medicines, GLP-1 and dual GIP/GLP-1 receptor agonists such as Ozempic, may delay passage of food through the stomach (gastric emptying). This poses a potential risk for patients during general anaesthesia or deep sedation. Source: TGA
Stability testing contributed by Jake Golding from PharmaGreen Consulting
The ICH revision to ICH Q1: Stability Testing of Drug Substances and Drug Products Step 2 document has been issued (11 April 2025) for public consultation. The ICH will issue a combined single guideline focused on core stability principles, ICH Q1, with integrated annexes that address specific topics. The revised guide will reduce ambiguity, address gaps, and include stability considerations for advanced therapies. There will be an increased emphasis on the application of risk management principles. The current draft can be found here: This is not the final document and there may be significant changes based on public consultation. The deadline for comments is by 15 July 2025. See the ICH website for more information.
USA news contributed by Neil O’Flaherty, AWG Law.
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities. Read more on FDA website here.
Note: Australian licensed manufacturers should not be too concerned, we already have the highest standards of GMP. HOWEVER we are preparing a short course on what to expect from a US FDA inspection. If that interests you please drop us a line info@regulatorytrainingdirect.com
For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.
Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories. contributed by Michael Levin, Health Business Strategies LLC
* Essential Oil adulteration. This article discusses the difference between contamination and adulteration – “Adulteration is intentional, a deliberate act to alter the product for economic gain. Contamination, on the other hand, is usually accidental, resulting from poor handling, equipment residue, environmental exposure, improper storage, or trace-level unintended cross-botanical contaminations”. Six different types of adulteration are listed. A very comprehensive article, published on LinkedIn here.
* For lovers of curry: 870kg of adulterated ginger/curry paste was seized during a raid at an illegal Indian ginger/garlic paste manufacturing unit operating under the name FK Food Product in Patel Nagar, Bandiaguda, Hyderabad, from the home of Modammed Faisel, the operator of this illegal unit. He was charged with adding harmful, banned additives such at titanium dioxide and mono citrate. Source: Times of India
* Suppliers of foods to the USA may need to be audited Source: FDA. Also refer to Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Human Food, available here
* Botanical Adulterants Monitor – read it here.
Foods
World Food Safety Day – 7th June. Read more on the WHO website here.
FSANZ and Health Canada collaborate on pre-market GM food assessments. This allows food developers to submit an application for joint assessment. One agency leads the scientific assessment, while the other reviews the results independently, with each agency making its own decision. Source: FSANZ
A dietary exposure assessment is the process of estimating how much of a food chemical a population, or population sub group, consumes. These assessments consider the potential exposure of the Australian and New Zealand populations to chemicals like food additives, pesticide residues, chemical contaminants, nutrients, food ingredients and other substances that have a nutrition or health purpose. A new video explains the process.
Amendments to Food Standards Code:
A1302 – Food derived from insect-protected corn line MZIR260
Approvals:
A1279 – Lentinula edodes (Shiitake mushroom) mycelia as a processing aid
A1307 – Milk fat globule membrane as a nutritive substance in infant formula products
A1308 – 2′-FL from GM Escherichia coli W in infant formula products
A1310 – Food derived from insect-protected soybean line MON94637
A1311 – Prolyl oligopeptidase from GM Trichoderma reesei as a processing aid
P1064 – Australian only Infant Formula Product Standard
Once FSANZ has notified the Food Ministers’ Meeting of its decision, it has 60 days to either request FSANZ to review the approved standard or inform FSANZ that it does not intend to request a review.
Call for submissions
A1288 – Thermolysin from Anoxybacillus caldiproteolyticus Rokko as a processing aid for protein hydrolysis in: dairy foods, egg, meat, fish, yeast, protein concentrates and isolates, and brewing. FSANZ is asking for submissions and comments. Submit your response here..
New applications
A1329 – Exclusion of Blacklip Rock Oysters from the maximum level for cadmium in molluscs
Information page on food allergens. All food businesses are responsible for managing the presence of allergens in food and must follow rules set out in the Australia New Zealand Food Standards Code. Published on NSW Food Authority website here.
Food recall statistics – updated 1st May. Undeclared allergens continues to be the biggest reason for recalls. Read more on FSANZ website.
Recalls
* Protea Foods Pty Ltd are conducting a recall of Lekker Biltong Slices Traditional and Lekker Biltong Slices Peri-Peri Chilli – packaging fault resulting in microbial contamination (mould). Source: NSW Food Authority
* Update to previous notice: SSM International is conducting a recall of Coco2 Infant Formula Stage 1, Coco2 Follow-on Formula Stage 2, and Coco2 Toddler Drink Stage 3 – due to labelling (incorrect scoop size and labelling errors). For more information about pack sizes and batch numbers see NSW Food Authority.
* Silver Pacific is conducting a recall of Laohenghe Dressing Sauce – due to the presence of an undeclared allergen (peanut). More information: NSW Food Authority
* Arepa for Calm & Clarity, and Arepa for Performance – due to a packaging fault resulting in the presence of glass. Source: NSW Food Authority
* Chinar Bakers – Frozen Cream Bun, Frozen Eggless Cream Roll – due to presence of an undeclared allergen(s) (Soy) Source: FSANZ
* a2 Milk Company – a2 Light Milk – due to Microbial (Listeria monocytogenes) contamination. Source: FSANZ
* Harvest Road Oceans – Albany Rock Oysters RO-Bistro and RO-Bottle – due to Microbial (E. coli) contamination. Source: FSANZ
* Fresh Frontier – Spicy Chicken Mango Pasta Salad – due to Microbial (Listeria monocytogenes) contamination. Source: FSANZ
* Barossa Fine Foods – Herb Crumbed Chicken Tenders – some products do not declare the presence of the allergens (gluten, wheat). Source: FSANZ
New Zealand Food safety insights, emerging risks, and current issues bulletins:
These bulletins contain news from all over the world.
* 8th May
* 22nd May
New Zealand food recalls:
* Alphagen NZ is recalling specific batches of its Ārepa brand The Brain Drink for Performance as the product may cause injury due to a packaging fault (chipped top of glass bottle). Source: NZ Ministry for Primary Industries
* Chopped Limited is recalling a specific batch of its Chopped brand Pure NZ Galloway Beef Thin Beef Sausages and Beef Traditional Beef Sausages due to the presence of an undeclared allergen (gluten). Source: NZ Ministry for Primary Industries
* Asian Savour World – Binggrae brand Power Cap Watermelon flavoured Ice Tube due to the presence of an undeclared allergen (milk). Source: NZ Ministry for Primary Industries
* Summer Harvest brand Bar Mix and Bhuja Mix Hot due to the presence of an undeclared allergen (peanut). Source: NZ Ministry for Primary Industries
* Sunson International is recalling all batches and all dates of Haichijia brand Hua Jia Jiang Hu (Clam Vermicelli) due to the presence of undeclared allergens (gluten, wheat). Source: NZ Ministry for Primary Industries
For regular news on US dietary supplement and food regulation, go to Regulatory Roundup.
Cosmetics and TGA listed sunscreens
Simplified process for reporting obligations for listed introductions. On 25 July 2025, AICIS will implement changes to help introducers comply with reporting obligations for listed introductions that have a specific information requirement (SIR).
These include:
* Improving Inventory chemical records so it’s easier for introducers to find the information they need when there are SIRs
* Updating and expanding guidance so it’s easier for introducers to work out if they need to provide information to AICIS
* Improving SIR online forms so it’s easier for businesses to give information to AICIS.
Read more on AICIS website.
New business platform – AICIS Business Services will switch to the ANZ Worldline payment gateway for all banking and card services in mid-June. According to AICIS “Our users won’t need to do anything differently.” Read more here.
Variation of inventory listing following revocation of CBI approval (19th May): One chemical, CAS 1617515-18-0. Source: AICIS
List of new chemical assessment statements as at 5th May: 18 assessments published. Of these, 4 are components of, or fragrance ingredients in cosmetic and household products. Source: AICIS
Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply) as of 8th May: five chemicals listed, all are silicic acid compounds. Source: AICIS
Chemicals added to the inventory following issue of assessment certificate (none in May)
Additional cosmetic news contributed by Rita Sellars, pH Factor
* I make cosmetics – do I need to register – Downloadable Factsheet. As we are starting to see more and more manufactures and brands importing cosmetics… this is a good summary. Also, from the industry we see people who are “making” their products at home and buying ingredients from overseas … people may forget that they need to therefore register with AICIS.
* Cosmetic ingredients labelling guide and list of recent cosmetic recalls published on www.productsafety.gov.au
In the press:
Cosmetic crackdown: End looms for speedy Botox scripts, influencer freebies banned. Published in Sydney Morning Herald. Includes “Speedy telehealth consultations granting patients access to Botox, lip fillers and other beauty treatments will become “unviable” under a crackdown on Australia’s booming cosmetic injectables industry.
New guidelines to be released on Tuesday by the Australian Health Practitioner Regulation Agency (AHPRA) also ban cosmetic injectors from offering free or discounted cosmetic injectables to social media influencers, and will prevent nurses entering the lucrative sector straight out of university. The changes follow revelations in this masthead in March that some Australian doctors were using telehealth to spend as little as 52 seconds with patients before writing a script for cosmetic injectables such as Botox and fillers.”
ACCC and similar
ACCC
Thermomix has paid $79,200 for making misleading representations to consumers suggesting two of its appliances – Thermomix TM6 cooking product and Kobold cordless vacuum and mop – were endorsed by the National Disability Insurance Scheme. Source: ACCC.
Regulating for sustainability: business integrity, innovation, and impact. Includes greenwashing, greenhushing and market integrity. A speech delivered by Chair of the ACCC on 27th May. Transcript is 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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