The Supplement: July 9 2024

At CMA, we’re ringing in the new financial year with a double dose of new beginnings – a brand new website and a new-look ‘The Supplement’ newsletter.

Our website has been long overdue for an overhaul and we’ve rebuilt it from the ground up. The team has worked hard to create a brand new website that not only better reflects who we are as an organisation, but allows us to offer you even more member value.

You can check it out now at cmaustralia.org.au.

Our new Member Portal within the website is where you’ll find all the exclusive member-only resources and information. Keep reading to find out more about it, plus how to access it. The beauty of this new website is its adaptability, and we can keep adding features and resources to the Member Portal as needed. So if you have any thoughts on resources or tools we could include which will help you, we’d love to hear about them.

On a final note, there are a number of exciting international industry events coming up soon, including Growth Asia in Singapore. If you’ll be attending Growth Asia, please let us know – we’d love to connect with you there.

John O’Doherty

Regulatory Updates

TGA Safety Advisory: Compounded colic preparations containing Atropa belladonna

The TGA has published a safety alert about Compounded colic preparations containing Atropa belladonna following reports of adverse events in infants and children. The TGA are investigating the issue to determine whether actions are needed. The safety alert provides information for consumers and health professionals about the medicine safety concerns related to the use of compounded colic preparations.

New TGA Consultations

The TGA has published two new consultations on their Consultation Hub:

The TGA has published a new consultation, closing 6 August, ‘Legislating regulatory categories for some boundary and combination products’, which are relevant to products sponsored by CMA members. The proposal would divide specific subcategories of the below products into different regulatory classifications: “Medical Devices”; “Medicines”; or “Medical Devices (exempt)”.

Products under the current proposal that are more likely to affect CMA members include:

  • products for lice on the head and body
  • oral care toothpastes
  • compounded and uncompounded emollient and moisturising preparations for therapeutic use
  • Ingested weight loss treatments.

Click here for more information. 

The TGA has published a new consultation on their Consultation Hub ‘Reforming Australia’s Therapeutic Goods Testing Regulations’, closing 5 August, outlining a number of legislative reforms to Part 5 of the Therapeutic Goods Regulations 1990 that sets out procedures enabling the examination, testing and analysis of goods conducted by the TGA Laboratories.  

The TGA are seeking feedback on 8 proposals to determine whether the changes are fit for purpose to increase protections without increasing unnecessary compliance burdens.

Click here for more information.

TGA Safety Advisory – Andrographis paniculata and anaphylaxis

The TGA has published an updated safety alert about Andrographis paniculata (andrographis) and anaphylaxis following continued reports received by the TGA of anaphylaxis and/or hypersensitivity reactions to medicines containing Andrographis. The advisory provides information for consumers and health professionals to be aware of the potential of andrographis containing products to cause adverse events.

The TGA has advised that they are evaluating this safety concern and considering whether the current allergy label warning for andrographis is sufficient to address this risk; and are advising Sponsors that all serious adverse events and significant safety issues must be reported to the TGA within the required timeframes detailed in the Pharmacovigilance responsibilities of medicine sponsors. The CMA Regulatory Committee will be discussing this matter next week. CMA welcomes any information or member feedback via technical@cmaustralia.org.au.

Reduced TGA inspections; Extended GMP certificates

CMA are pleased to advise that with the support of TGA-Industry Working Group on GMP (TIWGG) stakeholders including CMA, the TGA will shortly be introducing some efficiency measures: extended validity of GMP certificates to 4 years, as well as “Surveillance inspections”:

  • Full-scope, reduced-duration inspection (including reduced fees).
  • Only once per manufacturing site.
  • Only for applicable to a re-inspection where the site has a good history of compliance.
  • Manufacturers do not need to apply, the TGA will determine when one can be conducted.

It is anticipated the TGA will shortly publish  information on surveillance inspections on the TGA website in the coming days.  

Request for certificates or certified copies of TGA licences and certificates

The TGA has published a webpage containing a form to request:

  • Certificate of GMP Compliance
  • A certificate produced with a unique number. Electronically signed and issued by e-mail to the Client
  • Certified copy of original Certificate of GMP Compliance
  • Certified copy of original GMP Licence
  • Certified copy of original Quality Systems Certificate
  • Certificate of GMP Compliance for Mutual Recognition Agreement (MRA)

TGA Presentations – ARCS conference June 2024

The TGA has published presentations provided at the ARCS annual conference on 12 and 13 June 2024. These presentations, available here, include:  

  • Update from Manufacturing Quality Branch
  • TGO 92 compliance workshop
  • Update from the Complementary and OTC Medicines Branch
  • Risk management
  • TGA clinical trial landscape updates
  • Update from the Pharmacovigilance Branch
  • Nitrosamine impurities in medicines

TGA Recalls and Pharmacovigilance communication

CMA have become aware that some recalls and pharmacovigilance communication from the TGA is being sent to the wrong member of a company (even though the correct company contact is noted in eBS). In order to investigate this issue more thoroughly, CMA are seeking further details and specific examples from affected members to provide to the TGA, including details about whether the issue is with direct communication about products, or something else. Members are invited to provide these details via technical@cmaustralia.org.au.  

TGA Cost Recovery Implementation Statement 2024-2025

The TGA has published the Cost Recovery Implementation Statement (CRIS) 2024-25, which provides information on how the TGA implements and cost recovers its regulatory activities. 

Versioning of TGA Compositional Guidelines

In May 2024, CMA requested versioning of the TGA Compositional Guidelines (CGs) documents to assist members in understanding what is new and what has changed and when. The TGA has agreed to include a version history from now on for amended CGs. 

NZ Ministry of Health: Therapeutic Products Act Repeal Bill introduced – submissions now open

The New Zealand Government officially announced on 8 May 2024 that the Therapeutic Products Act (2023) will be repealed. The Therapeutic Products Act had intended to set up a new regulatory regime for natural health products in New Zealand. The Therapeutic Products Act Repeal Bill has now been referred to the Health Committee and the Committee has called for submissions from the public. This will be an opportunity for stakeholders to have their say about the repeal Bill. To lodge a submission, visit the NZ Parliament website. The closing date for submissions is 29 July 2024. Further guidance on making a submission can be found on the NZ Parliament website.

USP compendial updates

USP has published new compendial updates, including a new Notice and Monograph for Cetyl Palmitate; and New Notices of Intent to Revise Cranberry Fruit Juice Dry Extract. These notices help inform stakeholders of the changing status of USP monographs and general chapters and other USP standards-setting initiatives.

The American Botanical Council (ABC) -New BAPP bulletin Damask Rose Essential Oil

The ABC has published a new Botanical Adulterants Prevention Program (BAPP) bulletin for Damask Rose Essential Oil. These BAPP bulletins contain information about ingredient and product adulteration relating botanical adulterants.  

For a summary of other current regulatory news and information, transition date reminders, open and closed consultations, and education and training opportunities, please see  our full newsletter here.

In Memory of Stephen Myers

It is with great sadness that we learned of the passing of Emeritus Professor Stephen Myers recently.

Stephen was a giant in the field of complementary medicine in Australia. He was not only a gifted naturopathic and medical practitioner, but a leading researcher and tireless advocate for our industry and professions. His qualifications in naturopathy, western medicine, and pharmacology uniquely positioned him as one of Australia’s foremost authorities in the field. He was committed to expanding the evidence base of complementary medicine through his own research and powerful advocacy efforts.

Click here to read more.

CMA Website Member Portal

Welcome to the brand new Member Portal on the CMA Website. This is where you’ll find all the exclusive member-only resources and information including tech alerts, consultation information, regulatory resources, and access to IMGateway.

To access Member Portal, click the green Member Portal button near the top right of the CMA homepage.

Since this is a brand new platform, you’ll need to create a new password to access it. You should have already received an email prompting you to do so, or if not, you can also click this link. Your username will be the email address you received this newsletter to.

We will send you more updates shortly about how you can find everything you need, and get the most out of Member Portal.

If you have any issues logging in, please reach out to Paul on paul.seitz@cmaustralia.org.au.

Member Spotlight

ADM, a global leader in innovative solutions from nature, is proud to announce that its spore-forming probiotic DE111™ (Bacillus subtilis) has received official approval from the Therapeutic Goods Administration (TGA) in Australia. This approval marks the first Bacillus subtilis strain to be endorsed by the TGA, underscoring the company’s commitment to providing exceptional quality and safe gut health-supporting solutions.

Clinically documented results demonstrated that DE111™ is capable of supporting digestive health and healthy immune function, among other benefits such as supporting microbiome diversity.

Helen Hu, president of health & wellness APAC at ADM, highlighted, “By expanding access to DE111™, we’re facilitating new innovation possibilities for our Australian customers. This robustness is paving the way for new, convenient and enjoyable foods, beverages, and dietary supplements that meet people where they are on their wellness journeys, especially as more consumers make the connection between their gut and digestive health and other aspects of well-being.”

Events Calendar

Upcoming CMA and industry events to mark in your diary.

13-17 July, International Congress on Natural Products Research, Krakow, Poland

16-18 July, Growth Asia Summit, Singapore

18-20 September, Vitafoods Asia, Bangkok, Thailand

28 October – 1 November, Supply Side West, Las Vegas, USA

5-10 November, China International Import Expo, Shanghai, China

19-20 November, GMP Forum, Melbourne

21 November, Natural Health Products NZ Innovation Expo, Auckland

5 December, CMA Annual Conference & 25th Industry Awards, Sydney

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