The Supplement: 24 May 2024

A WORD FROM JOHN

Following on from a Budget Week which was very focused on domestic manufacturing, it was great to have the opportunity to talk with Prime Minister Anthony Albanese last night about the incredible Australian complementary medicines sector.

I was fortunate to also have the opportunity to discuss this with Shadow Health Minister Ann Ruston earlier this week.

As we all know, prevention is always better than cure. Our industry makes a substantial contribution to the health and wellbeing of Australians – and people around the world.

Having these conversations with policymakers is incredibly important. CMA will continue to push for greater recognition by Governments of the significant role our sector can play in preventive health. This benefits individuals, the health budget and helps to take pressure off the health system.

Naturally Good

If you’re heading to Naturally Good in Sydney (3-4 June), please be sure to pop by the CMA stand to say hello to the team. We’ll also be presenting on ‘Australia’s thriving complementary medicines sector’ on Monday at 12.30pm on the ‘Nourish Stage’. I hope you can join us.

Membership renewals

As we head towards the end of the financial year, we’re now starting the process for membership renewals for FY25. I cannot thank you enough for your ongoing support of CMA. Your support allows us to continue advocating for our industry, as well as supporting your organisation.

Over the past ten months, I’ve had the opportunity to meet with many of you, to learn more about your organisation and understand how CMA can best serve your needs. It’s clear that the work we do in regulatory, advocacy and lobbying is most valued – so we’re investing in extra resources to support this more than ever.

As part of the renewal process, this year we’re asking members to complete a turnover declaration. While we haven’t always done this annually in the past, we will be measuring our industry’s turnover each year going forward. It’s an incredibly important indicator for us.

The data collected on these forms allows us to correctly calculate fees, as well as assists us in gathering data on the size of our membership base and the complementary medicines sector more broadly.

Combined with the next Member Survey, which will be released shortly, we’ll be gaining a better understanding of the make-up of our industry, the needs, challenges and opportunities.

As always, please don’t hesitate to reach out if I or any member of the team can be of assistance.

I hope you all have a lovely weekend.

John

REGULATORY NEWS

New Manufacturing Principles published – PIC/S Guide to GMP PE009-16 effective from 3 June 2024 with a 3 month transition for Annex 16.

On 23 May 2024, the Therapeutic Goods (Manufacturing Principles) Amendment Determination 2024 was published on FRL, which amends the Determination to declare version 16 of the PIC/S Guide to GMP – PE009-16 – as the TGA’s Manufacturing Principles from 3 June 2024. However, Annex 16 will not be effective until 3 September 2024. CMA is aware that some members are concerned about Annex 16 and have taken the following actions:

  • Requested and obtained an extension on Annex 16, to September 2024;
  • Requested the TGA do not change existing expectations for Release for Supply, and provide interpretative guidance for Annex 16 on the areas of concern for the CM industry, including audit reports, authorised persons, etc – the TGA will publish this information in June.
  • Requested the TGA update the Release for Supply guidelines with improved information and examples, which is currently in process in consultation with CMA and other industry groups, and is expected to be published in 3rd quarter of 2024.
  • Provided members with preliminary interpretative information from the TGA to help understand how TGA expectations on Annex 16 will be mitigated, available here.

TGA’s Release for Supply Guidelines – CMA needs your feedback!

CMA is continuing to work with the TGA on a major update to the Release for Supply guidelines, which will support the introduction of the PIC/S Guide to GMP, Version 16 (PE009-16) as the Manufacturing Principles in Australia, including Annex 16 from 3 June 2024 with an anticipated 3 month transition period. CMA need your feedback (technical@cmaustralia.org.au) on what the guidelines should include:

  • What needs clarifying about Release for Supply?
  • What RFS situations do you want to see as examples in the updated guidelines?

Compositional Guidelines

A compositional guideline for Docosahexaenoic acid (DHA) rich oil extract from microalgae Schizochytrium sp. was updated in May, following Theanine published in March.

Australian Dietary Guidelines – March/April communiqués now available

The NHMRC has published the latest Dietary Guidelines Expert Committee meeting communiqués  on the NHMRC website. Work is continuing to focus on identifying available evidence and determining critical gaps where additional research may be required. There has also been discussion specifically related to the dietary needs of older Australians. Click here for more information.

Research: Mass spectrometric analysis strategies for pyrrolizidine alkaloids

This paper provides an overview of the structure, toxicity properties and commonly employed analytical methods, focusing on the concepts, advances, and novel techniques and applications of MS-based methods for the analysis of PAs. Additionally, the remaining challenges, future perspectives, and trends for PA detection are discussed. This review provides a reference for toxicological studies of PAs, content monitoring, and the establishment of quality control and safety standards for herbal and food products.

DOI: https://doi.org/10.1016/j.foodchem.2024.138748

Australian IP Report 2024

IP Australia has released the latest Intellectual Property report providing expert trend analysis using the latest intellectual property (IP) statistics. Key highlights include information on increased Australian filing, clean energy patents, and the increasing contribution of small and new firms to Australian innovation. Access the full report here.

Important Dates

TGA advisory committee vacancies including ACCM: Closing Sunday 26 May

Having experts with a strong understanding of complementary medicines in these positions is instrumental in shaping crucial TGA decisions and influencing broader complementary medicines regulation. Professionals and consumers with relevant expertise are invited to apply. Click here for more information or to apply.

Online Demonstration: Navigating the New FRL

Navigating some legislative documents on the FRL is necessary for all business areas required to access legislation relevant to their core business including Regulatory, Legal, Marketing, Manufacturing and Innovation. A demonstration of the new Federal Register of Legislation website will be held online, Thursday 30 May 2024, 14:00 – 15:00 AEST. Register here to attend.

GMP Forum 2024 website now open

The TGA’s Good Manufacturing Practice (GMP) Forum will be held on 19-20th November 2024 at the Melbourne Convention & Exhibition Centre. The Forum provides an opportunity to network with GMP experts and to engage directly with regulators. Australian manufacturers and sponsors of complementary medicines, including those in quality assurance, quality control, validation and regulatory affairs roles, are encouraged to attend. The website is now live and can be accessed here. Registrations open in June.

Participation opportunity: Statement on Consumer and Community Involvement in Health and Medical Research

The NHMRC and the Consumers Health Forum of Australia Ltd (CHF) are collaborating to review the 2016 Statement on Consumer and Community Involvement in Health and Medical Research. It articulates the importance and benefits of consumer and community involvement in research, and discusses a series of implementation issues. Interested stakeholders are encouraged to respond to the position paper through NHMRC’s Consultation Hub by Friday 31 May 2024.

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

EXPORT NEWS

India Update: Registration of Foreign Food Manufacturing Facilities

CMA recently advised members that the Food Safety and Standards Authority of India (FSSAI) has issued a new order (April 2024) related to requirements for the registration of foreign food manufacturing facilities, and that the relevant overseas manufacturers must be registered by 31 August 2024. CMA provided DAFF/TGA with all the required information for contract manufacturers to be registered with the FSSAI before the original enforcement date in 2023 (Ref: India update: 21 Nov 202223 Nov 2022). However, we are still not able to confirm that relevant contract manufacturers’ information has been listed by FSSAI. CMA has been in contact with the Australian High Commission in India to raise our concerns that if contract manufacturers are not properly listed by the FSSAI it may lead to products being held up by India customs post August 2024.

Following ongoing communications with the Australian High Commission, they have confirmed that DAFF will provide FSSAI with an updated list of all establishments that need to be listed on the FSSAI portal in advance of the August deadline. For those who currently export to India, if there are any errors on FSSAI’s portal that need to be corrected (e.g., missing listings, incorrect titles), please send them to Miho in Excel format by Friday 7 June 2024 so that CMA can forward a consolidated list to DAFF accordingly.

HEALTHPLEX

Only 4 more weeks to go until Healthplex!

It has been very busy couple of months for CMA getting ready to host the Australian pavilion at this year’s Healthplex. With the cooperation of various stakeholders, including our China partner, the China Chamber of Commerce (the CCCMHPIE), the pavilion constructor, Austrade, Investment NSW, and Australian exhibitors, CMA has been focused on finalising the Australian pavilion and a schedule of events for this year’s Healthplex.

Events will include the Australian pavilion launch, which will be kindly hosted by Investment NSW and Blackmores, the MOU ceremony between CMA and the CCCMHPIE to celebrate our ongoing partnership, and the Australian Brand Show to showcase exhibitors’ world-leading products and innovative manufacturing capabilities. Australian exhibitors are also invited to attend the Gala Dinner and the B2B matchmaking event. It is expected to be a very busy and productive 3 days in Shanghai next month for Australian exhibitors, and we look forward to keeping members updated on these events. Click here to read the Australian Pavilion Booklet (2024).

If you wish to be part of the Australian pavilion at Healthplex in 2025, please forward your EOIs to Miho.

WELCOME TO CMA

CMA welcomes our newest member, MCC

Get to know them them a bit better below:

As the global leader of premium labels, MCC helps brands stand out in competitive markets and inspire positive consumer experiences. MCC has eight sites across Australia and four in New Zealand, with a unique ability to service and supply local clients with both self-adhesive labels and also digitally-printed folding cartons. Ensuring your packaging aligns to both consumer needs and regulatory requirements is crucial. Our team of technical experts leverage the most current industry standards to ensure your packaging checks all the boxes. Our broad range of print technologies help ensure your packaging goals are achieved and will cater to any type of product launch. Whether you’re interested in printing a smaller quantity promotional run, to printing a large quantity for your flagship product, MCC is the partner for you.

We are perfectly suited to manage the complexities of this industry including multiple SKU’s, frequent changes, and responsive service levels. MCC is focused on the future by developing consumer-driven innovations and sustainable packaging solutions, alongside an unmatched collection of specialised materials, innovations, embellishments and effects.

EVENT NEWS

CMA Innovation Day – Event Photography

Thank you to all those who attended the CMA Innovation Day on 7th May 2024 at Dockside. Photographs from the event have been uploaded to the CMA website, please click here to view them.

If you would like to receive any images in high resolution, please contact us.

Speaker Presentations

CMA have shared instructions to view the speaker presentation slides with delegates via email. If you have not received the instructions and would like to view the content, please contact us.

GROWTH ASIA SUMMIT 2024

In case you missed it: CMA members can access an exclusive discount for the Growth Asia Summit, which returns to Singapore in July.

Organised by NutraIngredients-Asia and FoodNavigator-Asia, the event will feature extensive expert insights from big-name brands, leading academics, market and trends specialists, policy experts, and the most innovative suppliers. Alongside CMA, other confirmed speakers include senior leaders from H&H Group, Blackmores, JS Health, BYHEALTH, Life-Space Group, ADM and many more.

Registrations are open now. Enter the code TRADEGA24 when registering to take advantage of a 25% discount. For the full program and tickets, click here.

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