Technical Alerts

On 1 March, the TGA amended a public consultation on amygdalin and hydrocyanic acid, which affects 22 herbs used by complementary medicine practitioners and/or are permitted to be included on the ARTG, including Wild Cherry Bark.

The amendment to the consultation, which closed on 12 April, proposed an increased allowance to amygdalin and hydrocyanic acid in therapeutic preparations. This amended proposal was based on an advocacy appeal by CMA to the TGA to consider that the total ban on amygdalin and the restrictive ban on hydrocyanic acid, which are both naturally occurring in some plant materials, was too restrictive to allow supply of particular herbs. Despite this,  the TGA consultation also proposed a new Schedule 10 entry in the Poisons Standard for Wild Cherry Bark (Prunus serotina) which, if adopted, will result in a total ban on Wild Cherry Bark. The newly proposed Schedule 10 entry is due to TGA concern about high levels of amygdalin and hydrocyanic acid occurring in Wild Cherry Bark, and the potential for misuse.

In summary, CMA’s submission:

Supported the proposed limit of 10mg/kg hydrocyanic acid. CMA proposed that the 10mg/kg limit is specified in the Poisons Standard to apply only to plant preparations for therapeutic use rather, than all preparations for therapeutic use.

Partially supported the proposal to increase the limit of amygdalin in therapeutic preparations however, CMA did not support the TGA proposed limit of 10mg/kg. CMA’s submission proposed a permissible daily exposure per medicine of up to 1mg (without further controls) or up to 2.5mg (with additional regulatory controls such as a requirement for the preparation to be on the ARTG, a child resistant closure and a limited duration of use). This proposal is supported by intake levels determined to be safe by comparable scientific bodies, including the WHO/JECFA and FSANZ for both chronic and acute exposure, and takes into account any additional dietary consumption of foods and beverages that contain amygdalin and hydrocyanic acid.

Did not support the proposal to include Wild Cherry Bark in Schedule 10 of the Poisons Standard, as the substance is not subject to misuse and may be appropriately controlled according to the same proposals above for amygdalin and hydrocyanic acid .

Did not support the proposal to schedule Green Tea extract (GTE) (Camellia sinensis), as the proposal did not appear to support any functional outcome other than redirecting sports supplements with GTE in dosage forms such as powders, liquids and gummies onto the ARTG by way of the Therapeutic Goods (Declared Goods Order) 2019.

Please read CMA’s submission in full here.

Many members have been concerned about the advertising of illegal therapeutic goods on digital and social media platforms, which are non-exempt therapeutic goods that are required to be on the ARTG due to importation or supply in Australia, but are not (excluding valid personal importation).

CMA has raised this issue through our representation on the Therapeutic Goods Advertising Consultative Committee, and can provide members the following insights:

The TGA has established relationships with a number of digital platforms, including as eBay, Amazon, Meta and Tiktok, to prevent and remove unlawful advertising of therapeutic goods. These relationships allow the TGA to identify specific advertisements of concern and request the platforms to remove them.

The TGA also maintains regular contact with the platforms, to advise them of the TGA’s legislation, with the aim of preventing unlawful advertising before it is published. This advice may be general, or more specifically related to priority issues.

Individual platforms working with the TGA can establish custom solutions with significant impact. This often includes the development of filters to identify problematic postings. Other bespoke solutions may be forthcoming depending on the specific framework for each platform.

As an example, following liaison with the TGA, eBay amended their Prescription and over-the-counter medicines policy (including Listed medicines) to specifically require relevant listings to display the ARTG number, and the platform enforces this requirement via a custom field.

While the TGA has its own intelligence sources, the TGA cannot monitor all activity and also relies upon stakeholder reports of illegal goods on digital platforms to take further action. Please use the Reporting Portal on the TGA website for all reports of illegal goods on digital and social media platforms to ensure they are logged into the TGA investigation database.

CMA has established a line of reporting to elevate particularly egregious matters to the TGA. Contact CMA's regulatory affairs at technical@cmaustralia.org.au to report any serious concerns.

The TGA has published a notice of interim decisions for palmitoylethenolamide (PEA) on their website. The public consultation, closing 17 April, requests stakeholder feedback on the Delegate’s decision to amend the current Poisons Standard in relation to PEA by creating a new Schedule 6 entry that excludes derivatives and preparations for therapeutic use. The interim decision proposing to exclude all preparations for therapeutic use has adopted CMA’s recommendation which previously only included listed medicines.

If the interim decision is confirmed, listed and registered medicines on the ARTG and other therapeutic preparations (such as practitioner compounded medicines) containing PEA will be excluded from the new Schedule 6 entry and will be unaffected. As for all schedule 6 substances, there may be implications for storage, supply and transport of the material under States and Territories.

Please read today’s tech alert for more details.

The TGA has published a web page outlining the Therapeutic Goods Advertising and Compliance Education Plan for 2024.

Please read today’s tech alert for more information on the plan, including relevant aspects of each education priority to listed medicines, such as High risk traditional medicines and the use of Nicotinamide adenine dinucleotide (NAD) in complementary medicines.

The TGA has published an updated and improved version of the Assessed listed Medicine Evidence Guidelines. 

CMA has advocated for scientific improvements and greatly increased clarity, many of which have been implemented in this update. We expect these changes to reduce barriers for sponsors and researchers, make applications easier, and increase the chances of applicant success.

Notable updates that encourage greater confidence in the pathway include:

- Large improvements to scientific interpretations and assessment

- Easier literature-based submissions

- A more user-friendly document.

The TGA are committed to working on further future improvements in consultation with CMA. As always, we welcome your valuable member input.

Please click here for details of improvements!

Today’s tech alert (Click above) provides an update for members on the progress of the TGA’s Recall Reforms Program following public consultation in 2023 on potential changes to how product recalls are undertaken in Australia. 

This alert provides information for members, including changes to TGA processes and changes to improve clarity and readability of the URPTG in response to stakeholder feedback and the TGA’s next steps in progressing the recall reforms.

The TGA are introducing PIC/S Guide to GMP Version 16 (inclusive of Annex 13 and Annex 16), as the manufacturing principles for medicines from 3 June 2024 (PE009-16, 1 February 2022). Currently the TGA webpage does not discuss a transition however, CMA and other industry groups are discussing the length of a possible transition period with TGA.

More information from the TGA including Version 16 interpretive guidance on complying with PIC/S, which will particularly address Annex 16/ Release for Supply concerns, will be released in June. In the meantime, manufacturers can refer to this Gap Analysis between Version 15 and 16 (member login required) to help understand how TGA expectations under Annex 16 will be mitigated in the forthcoming GMP interpretive guidance.

For example, many in the Complementary Medicine industry have been concerned about Annex 16 new clause 1.7.3 (audit reports are available to the Authorised Person performing the certification). The Gap Analysis includes numerous comments against this clause, including for Listed medicines that:

The current supplier approval processes (questionnaires, testing of deliveries etc) would be considered sufficient ‘audit’ for listed medicines API manufacturer.

There is currently no expectation that additional audits will be conducted of listed medicines contract manufacturers in the supply chain in addition to those inspections conducted by the TGA or other approved regulator. 

It is deemed acceptable evidence for clause 7.4.1 that the contract manufacturer holds a TGA licence or certificate for the relevant steps in manufacture. 

CMA has joined a joint TGA-industry Working Group of the TIWG, which will rewrite the Release for Supply guidances to modernise the documents, and in view of the introduction f Annex 16. Sector specific information including on listed medicines will be included. 

To ensure the updated guidances will meet member needs, CMA is seeking your feedback on the following:

- What concerns do you have with the current Release for Supply guidances* and what could be made clearer?

- What questions or concerns do you have about Annex 16?

- After considering the Gap Analysis, how long do you think the transition period should be and what specific internal/commercial factors influence this?

- Do you have any other questions about Release for Supply to improve future guidance. Are there specific examples you would like covered in the guidance?

Please send your questions, concerns or suggested examples to clarify in guidance to Lucy.Lang@cmaustralia.org.au as soon as possible.

Further developments will be discussed with CMA's GMP & Manufacturing Committee, and CMA will send technical alerts when future TGA GMP guidances are published.

*Release for supply of medicines | Therapeutic Goods Administration (TGA)

Releasing medicines manufactured at multiple sites | Therapeutic Goods Administration (TGA)

The Department of Health and Aged Care (the Department) is conducting a Public Consultation on the final stage of the FSANZ Act Review, closing 10 April 2024.

The FSANZ Act Review has identified 27 concepts across four themes for further investigation, which have been consolidated into 20 components in an Impact Analysis. Stakeholders are being asked for their views on the Impact Analysis and to provide feedback to characterise the impact of the proposed concepts. 

Please read today’s full alert for more information, including aspects of the review that may be of potential interest to members such as:

- Definition of ‘public health and safety’ in the Act.

- Potential approaches toward a risk based framework.

- Potential new pathways to amend food standards.

- Potential to bring more Traditional Foods to market.

- Industry guidelines to guide interpretation of food standards.

The TGA has released public consultation on new proposals to amend the Poisons Standard in relation to:

- Amygdalin and hydrocyanic acid, providing a new cut-off limit effecting approximately 21 ingredients that is likely to give some greater certainty to industry and practitioners around the supply of products, cosmetics and raw materials with very low trace levels; and 

- a relate new  Schedule 10 entry for Wild Cherry Bark, effecting a total ban on Wild Cherry Bark for therapeutic use. 

The same consultation paper proposes cautionary statements for those Green Tea/Tea (Camellia sinensis) products that are not already on the ARTG and not in foods.

Sponsors, manufacturers, raw material suppliers, practitioners and other affected stakeholders are encouraged to read this full tech alert  for:

- important clarifying information on these proposals that CMA has obtained,

- specific information relevant to practitioners,

- background information,

- CMA’s draft positions, and

- details on how to effectively respond to the consultation.

This tech alert is publicly accessible and the link is permitted to shared with practitioner and other interested stakeholders. 

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024 commences today, Friday 1 March 2024.

This technical alert provides members with a summary of changes as well as a comparison table of all changes to the Determination.

Important changes in this Determination include:

NEW ingredients for use in listed and assessed listed medicines and specific requirements that apply to those ingredients:

- Addition of the new active ingredient theanine with exclusive use provisions for 2 years;

-Addition of the new excipient ingredient ceramide 6 II;

Addition of the new excipient ingredient sodium lauroyl lactylate; 

CHANGED ingredients including ingredients with NEW WARNINGS and other changed requirements:

- Curcuma aromatica; Curcuma longa (Turmeric); Curcuma zanthorrhiza; Curcuma zedoaria; and curcumin.

- Camellia sinensis (Green tea).

Ingredients with important changed requirements including

- Terminalia ferdinandiana (Kakadu plum); neohesperidin-dihydrochalcone (permitted for oral use in listed and listed assessed medicines); hemp seed oil, and other ingredients.

Please read today’s full alert for more details.