The Supplement: 21 June 2024

A WORD FROM JOHN

This week CMA is once again hosting the Australian Pavilion at Healthplex 2024 in Shanghai. This event has provided a remarkable platform to highlight the best of our Australian industry.

Thank you to all our exhibitors for showcasing your exceptional products and services. We are delighted to have Blackmores, Bluegum Pharmaceuticals, Ferngrove Pharmaceuticals, Homart Pharmaceuticals, Lavida Pharmaceuticals and Lipa Pharmaceuticals attending this year.

On Wednesday evening, we attended the Healthplex Gala Dinner, which hosted over 600 guests, including representatives from embassies, consulates, governments, exhibitors, industry experts, and associations. CMA was recognised with the ‘Healthplex Best Partner Award’. Congratulations to our members who also received awards.

CMA signed a formal Memorandum of Understanding with the China Chamber of Commerce for Import & Export of Medicines & Health Products. This celebrated our partnership, our friendship, and our commitment to continue working together.

China holds immense significance and opportunity for our industry. For many years, Australia and the United States have vied for the title of ‘Number One Exporter to China.’ It’s a title we hope Australia will reclaim in the near future, and I believe that events like Healthplex can significantly contribute to achieving this goal.

REGULATORY NEWS

For all of the latest regulatory news and updates from CMA, click here

Key updates this fortnight:

TGA Proposed Label Warnings for 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. Please see CMA’s 30 May Member alert for more details.

CMA will be sending an assessment form to sponsors and manufacturers in the near future, we encourage you to provide this form to CMA so we can assess sizes and overall impact and represent accordingly.

New TGA GMP guidance – PIC/S Guide to GMP PE009-16

The TGA has published new guidance on GMP requirements for medicinal products: PIC/S Guide to GMP PE009-16 – Version 16 of the GMP Code that was recently adopted as the TGA Manufacturing Principles, including comments against each clause in the newly adopted Annex 16 (Authorised person and batch release) relating to Release for Supply.

As there is currently insufficient clarity for manufacturers to understand their obligations on clause 1.7.3 (sharing of audit reports), CMA have lodged an objection to the required expectations and timeframes for manufacturers published on the TGA webpage.

CMA recommends that all manufacturers of listed medicines, including all Authorised Persons conducting Release for Supply, read CMA’s tech alert for all context and details.

OCEBM Update to TGA Assessed listed medicines evidence guidelines

In April 2024 CMA requested that the link to the Oxford Centre for Evidence-Based Medicine (OCEBM) Levels of Evidence in the AUST L(A) guidance be updated to the 2011 version. In response to CMA’s identification of this issue, the TGA has published an update to the Assessed listed medicines evidence guidelines to version 1.3, June 2024, with a correction to the link to the OCEBM Levels of Evidence (page 28). There is no other change to the guidelines. Please read CMA’s 17 June tech alert for more recent context on using real world evidence and of N-of-1 trials.

New TGA guidance – Cosmetics or therapeutic goods

The TGA has published new guidance that aims to assist sponsors and advertisers in determining if a product is a cosmetic or a therapeutic good, which based on a number of different factors that need to be considered on a case-by-case basis.

Read CMA’s 11 June tech alert for more details, background on CMA advocacy during the development of the guidance, and additional resources.

EFSA: Scientific opinions on the tolerable upper intake level for preformed vitamin A and β‐carotene; and iron

EFSA has published scientific opinions on the tolerable upper intake level for preformed vitamin A; and iron on 6 June and 12 June, respectively:

●      The EFSA Panel on Nutrition proposes to retain the Upper Limit (UL) for preformed vitamin A of 3000 μg RE/day for adults. This UL applies to men and women, including women of child‐bearing age, pregnant and lactating women and post‐menopausal women.

●      The EFSA Panel on Nutrition has established a safe level Upper Limit (UL) for iron of 40 mg/day for adults (including pregnant and lactating women).

New on FRL: Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024

A  new Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024 commenced Friday 14 June 2024. Important changes in this Determination include:

NEW ingredients for use in listed and assessed listed medicines and specific requirements that apply to them include: new active ingredient Bacillus subtilis with exclusive use provisions for 2 years; new excipient ingredients behentrimonium metilsulfateD-glucosepolymer with xylitolpolyglyceryl-2 isostearat1,8,12-bisabolatriene.

CHANGED ingredients including: amendments to Litchi chinensisnonivamideEuglena gracilis whole cell dryBeeswax alcohols.

Please read CMA’s 13 June tech alert for more details, including a summary of changes as well as a comparison table of all changes to the Determination.

New on FRL: Therapeutic Goods Legislation increasing annual fees and charges for Therapeutic Goods

The following legislative instruments have been published on the FRL:

●      Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024

○      Explanatory Statement

●      Therapeutic Goods (Charges) Amendment (2024 Measures No. 1) Regulations 2024

○      Explanatory Statement

●      Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024

○      Explanatory Statement

Note: the 4.7% indexation increase in fees and charges outlined in the above legislative instruments are in addition to the additional percentage increases on fees and charges relating to digital transformation costs among others, effecting a total of 6.71% for medicines and 6.30% for manufacturing licences for the 2024-25 financial year. Please see CMA’s 30 January member alert for more details on the TGA’s proposals via public consultation earlier this year.

IP Australia: Plant Varieties Journal update

IP Australia has published the latest issue of the Plant Varieties Journal (Vol.36 No.4). The Plant Varieties Journal publishes details on acceptances, variety descriptions, grants and variations quarterly.

CMA welcomes our newest member, Vitex Pharmaceuticals. Get to know them them a bit better below:

“At Vitex Pharmaceuticals, we’re honoured to be recognised as Australia’s best-in-class CDMO for complementary medicines. Based in Sydney, we supply the leading household name brands and bestselling products, ensuring the highest standards of quality and reliability.

Our TGA-certified facility offers tablet compression/coating/chewables, soft gel capsules, two-piece hard gel capsules, and powders, along with comprehensive packaging solutions including bottle, blister, and sachet packaging. As a full turnkey provider, we offer concept-to-shelf solutions from initial product development to regulatory affairs and analytical testing, all conducted within our state-of-the-art in-house laboratories. Led by CEO and Co-founder Dr. Aniss Chami, who serves on the board of Complementary Medicines Australia (CMA), Vitex exports to markets across APAC, MENA, Europe, North America, and SEA regions.

As we expand our operations, we’re excited to introduce a new state-of-the-art pharmaceutical manufacturing facility spanning 50,000 sqm covering both Registered and Listed Medicines, slated to open in 2025. This major expansion aims to position Vitex among the largest manufacturing players both regionally and globally.”

Today is the final day of Healthplex 2024 in Shanghai, China, and CMA is here to once again host the Australian Pavilion. And this year we are joined by CMA members Blackmores, Bluegum Pharmaceuticals, Ferngrove Pharmaceuticals, Homart Pharmaceuticals, Lavida Pharmaceuticals, and Lipa Pharmaceuticals, who are successfully showcasing Australia’s exceptional products and services to China and the world.

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