The Supplement: 7 June 2024

A WORD FROM JOHN

It was great to see so many of you at the Naturally Good Expo in Sydney this week, and I was delighted to speak and share insights into some of the exciting developments, opportunities and trends currently shaping the future of complementary medicines. It’s always such an inspiring experience to witness firsthand the enthusiasm and innovation driving our industry forward.

I want to draw your attention to an important initiative we have coming up – our Member Survey. This will be the largest and most comprehensive survey we’ve ever undertaken. It aims to gain a detailed understanding of the make-up of our industry, along with the needs, challenges, and opportunities you face.

This survey is quite extensive and will take some time to complete, but your participation is invaluable, and we truly appreciate you taking the time to fill it out. Your responses will empower us to better advocate for you and represent our industry’s interests more effectively.

Additionally, our membership renewal forms have been sent out, which include turnover declarations. The information gathered through these forms is crucial for accurately calculating membership fees and helps us compile essential data on the size and scope of our membership base and the complementary medicines sector as a whole. Again, we very much appreciate your cooperation in completing and returning this form.

As always, please do not hesitate to reach out if I or any member of our team can be of assistance. Your support and engagement are what makes our industry strong.

John

REGULATORY NEWS

Unapproved Goods – Your Feedback Needed

CMA is working with the TGA on improving systems to address unapproved/illegal goods in Australia. We welcome your feedback to CMA on what is and is not working and what can be improved at technical@cmaustralia.org.au.

Important Consultation: TGA Proposed Label Warnings for Tablets, Capsules and other solid oral dosage forms

On 30 May, the TGA published a public consultation on proposed labelling changes on large solid oral dosage forms, closing 11 July 2024. This consultation includes significant proposals for new labelling requirements for Listed Medicines, that are:

●      a large solid oral dosage form; AND

●      intended to be swallowed whole; AND

●      over a certain size threshold.

Under the changes, new labelling would be required after a 2 year transition period, including:

●      a statement to warn consumers

●      an image of the dosage unit that is true to size with the words ‘actual size’

●      the statement ‘swallow with water’ in the directions for use.

Please see our 30 May Member Alert and the TGA consultation Hub for more details on how to respond to CMA and TGA.

Version 16 of GMP Code adopted

The TGA’s adoption of version 16 of the PIC/S Guide to GMP – PE009-16 (Version 16) were adopted as the Manufacturing Principles for medicines in the Therapeutic Goods (Manufacturing Principles) Determination 2024 via amendment on 3 June 2024. Annex 16 comes into effect on 3 September 2024. The TGA website is expected to be updated in the near future with Interpretative Guidance that will specifically address the concerns and questions raised by CMA for the complementary and listed medicine industry for the Version 16 and in particular Annex 6.

New on FRL: Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024

This instrument, available here, repeals and replaces the Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024, which had been in effect since 1 February 2024. The purpose of the Instrument is principally to revise the scheduling arrangements for several substances that are included in the current Poisons Standard, and to include a number of specified substances in the current Poisons Standard for the first time.

In relation to substances that have been introduced in the current Poisons Standard for the first time, the Instrument incorporates entries for:

●      in Schedule 5—benzoic acid (excluding its salts and derivatives), to provide that preparations containing more than 1% of this substance, and which are for agricultural use, require appropriate packaging with simple warnings and safety directions on the label. More information is available in the Explanatory Statement.

Final Scheduling decision delayed: palmitoylethanolamide (PEA)

The final scheduling decision for palmitoylethanolamide (PEA) has been deferred to a later date while the information provided during the interim decision consultation period is further considered by the TGA. Two submissions, including one from CMA, were received – both of which were in support of the interim decision. The Delegate’s interim decision was to vary the applicant’s proposal to amend the current Poisons Standard in relation to PEA by creating a new Schedule 6 entry, but which excludes derivatives and preparations for therapeutic use. More background information is available in CMA’s 8 April tech alert.

FSANZ Revised fee structure for applications

Proposed changes to the FSANZ cost recovery charging structure for applications are due to come into effect from 1 July 2024. The proposed changes include:

●      30% reduction to the maximum variable hours for all application procedures;

●      25% reduction to the refundable administrative charge from $1,000 to $750 (AUD);

●      Increase to the non-refundable fixed charge for applications from $19,470 to $22,608 (AUD); and

●      Increase to the hourly rate for authority personnel in line with salary increases.

For more information, contact the FSANZ Standards Management team via email at standards.management@foodstandards.gov.au.

New TGA blog posts

●      Making therapeutic goods safer for everyone – highlights to consumers the importance of reporting any side effects and problems they have related to medicines.

●      What you need to know about compounded weight-loss medicines.

Good Clinical Practice (GCP) Inspection Program

The TGA has published revised guidance on the Good Clinical Practice (GCP) Inspection Program to include clinical trials of medical devices. Clinical trials of medicines, biologicals and devices regulated under the CTN or CTA schemes are subject to the TGA’s GCP Inspection Program. The TGA GCP Inspection Program guidance for clinical trials involving medicines, biologicals and devices, describes:

●      the type of inspections the TGA may conduct

●      who the TGA inspect

●      how the TGA prioritise and schedule GCP inspections

●      how to prepare for an inspection

●      the inspection process, and

●      how the TGA report and follow-up on inspection.

USP Compendial updates

USP has published new compendial updates, including a Notice and Monograph for Succinic Acid, a new Revision Announcement for magnesium sulfate. These notices help inform stakeholders of the changing status of USP monographs and general chapters and other USP standards-setting initiatives.

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?

For a summary of current and recent regulatory news, information on new ABC HerbClips, ABC Herb profiles, New ESCOP Monograph (Dandelion Root), new and recent research snippets, transition date reminders, open and closed consultations, and education and training opportunities, please see our full newsletter here.

WE’RE HIRING

We are looking for a Manufacturing & Sustainability Regulatory Associate, to help strengthen the role of CMA in advancing the complementary medicines sector by educating, exercising influence, and developing technical proposals in the areas of manufacturing policy, GMP, TGA regulations, product development, packaging and sustainability. 

The role is remote (work from home within Australia) with occasional travel for meetings and events, and we offer flexibility for full time or permanent part-time.

Click here for the full job description and details on how to apply.

EXPORT NEWS

India Update: Registration of Foreign Food Manufacturing Facilities

(Deadline: Today)

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

The CMA team and exhibitors – Blackmores, Bluegum Pharmaceuticals, Ferngrove Pharmaceuticals, Homart Pharmaceuticals, Lavida Pharmaceuticals, and Lipa Pharmaceuticals, are heading to Shanghai next weekend, to showcase the very best of Australian complementary medicines at Healthplex, the most important and popularly attended nutraceuticals and health food expo in the Asia-Pacific.

It has been 5 years since we organised the last Australian Pavilion at Healthplex in 2019. We acknowledge that a great amount has changed during this period, which is why we are so excited to be able to return and host the Australian Pavilion again this year. Many representatives from the Chinese media have already contacted CMA to organise interviews with our CEO John O’Doherty during Healthplex. This is a true reflection of the significant level of interest from China towards Australian complementary medicines. We are very certain that the Australian Pavilion will be the busiest and most popular pavilion this year.

We cannot thank enough our China partner, the China Chamber of Commerce (the CCCMHPIE), Australian government agencies, such as Austrade and Investment NSW, and the Australian Made Campaign Limited for their continuing strong support over the last 6 months. Click here to read the Australian Pavilion Booklet (2024).

We look forward to sharing the outcomes of this year’s Healthplex with members soon.

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

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