Technical Alerts

The TGA is conducting a public consultation, closing Monday 20 March 2023, on the TGA’s proposed increase to fees and charges for the 2023-24 financial year by a total of 11.56% for medicines and 11.1% for manufacturing licenses.

This technical alert provides further information on the TGA Fees and Charges Proposal 2022-24, which describes the reasons for the proposed fee increases, including an increase of the indexation factor by 5.2% and the proposal to apply additional percentage increases on fees and charges relating to TGA building, laboratory, and digital transformation costs among others.

This alert also contains reference to CMA’s draft positioning relating to the increased fees and charges proposal.

Members may respond to the public consultation independently and may also provide any feedback to the consultation to CMA by Wed 15 March 2023  via technical@cmaustralia.org.au.

Further to CMA's 20 February tech alert, which provided a summary of changes to the Permissible Ingredients Determination (No. 1 of 2023), this technical alert provides members with a comparison table of all changes to the Determination, including: 

- NEW ingredients and specific requirements that apply to that ingredient.

- CHANGED ingredients with the original requirements and the new or changed requirements; including the end of the transition period, on 28 February 2023, for certain ingredients.

- DELETED ingredients if applicable.

Please read today’s full alert for more details.

The TGA has published a web page outlining new priority areas for compliance education activities relating to advertising of therapeutic goods for 2023, in alignment with the Import, Advertsising and Supply Compliance priorities 2022-23.

The plan has been developed in consultation with the Therapeutic Goods Advertising Consultative Committee (TGACC), of which CMA are a member and involved on ongoing engagement. CMA welcomes feedback, insights and input form industry members on any/all of the matters outlined, via technical@cmaustralia.org.au.

The TGA’s 2023 compliance education priorities include.

- Communication and education products relating to Import, Advertsising and Supply Compliance priorities 2022-23: including:

Performance and image enhancing therapeutic goods

Unapproved therapeutic goods on digital platforms

Medicinal cannabis industry compliance

Therapeutic goods used in beauty industry

-Timely communication on regulatory changes and emerging issues; including:

website information, webinars and training materials

- Publish information on compliance and enforcement activities for transparency and as a deterrent to non-compliance; including: 

Publishing information for stakeholders on outcomes of investigations of import, advertising and supply investigations

- Maintain and enhance fit-for-purpose educational resources on the TGA website and provide training and education opportunities; including:

Education campaigns

Advertsising hub improvements

Development of educational materials to support advertising compliance

Stakeholder engagement

Education and training

- Engage with key stakeholders, including members of the TGACC [including CMA] as partners in education and communication activities 

- Maintain and enhance an advertising enquiry management function

Resources 

- TGA web page: Therapeutic Goods Advertising and Compliance Education Plan 2023

- TGA web page: Therapeutic Goods Advertising Compliance Education Strategy 2021

- Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021

- TGA web page: How we manage advertising compliance

- CMA 26 July 2022 tech Alert: TGA Compliance Priorities 2022-23: Import, Advertising and Supply including unapproved goods, e-commerce supply of unapproved goods; COVID-19 or serious diseases; sports supplements, medicinal cannabis.

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023 commences on Wednesday 1 March 2023.

This Technical Alert contains a summary of new, deleted and changed ingredients.

A comparison table of all changes to the Determination will be provided to members upon commencement of the Determination, on Wednesday 1 March.

The TGA has published a Notice of Interim Decisions in relation to green tea extract and melatonin. The consultation on these interim decisions is open now, closing Friday 3 March 2023.

The Delegate of the Secretary has made the following interim decisions:

- not to amend the Poisons Standard in relation to green tea extract; this means that if the interim decisions is confirmed by the Delegate through this consultation in the final decision (due in several months time), there will be no change, and GTE will remain unscheduled; and

- to amend the Poisons Standard in relation to melatonin; to amend the Schedule 3 entry for melatonin to allow divided preparations containing 5 mg or less of melatonin, in packs of no more than 10 dosage units, for adults aged 18 and over to be prescribed by a pharmacist for the treatment of jetlag. This decision is to be implemented on 1 June 2023. 

Please read today’s full tech alert for more information on the Delegates reasons for these decisions and CMA's response to the proposal. 

The TGA has published an updated web page on Guidance on using evaluation reports from Comparable Overseas Bodies (COB). The changes to this guidance affect eligible:

- New substance (or changed substance) applications for the Permissible Ingredients Determination

- AUST L(A) applications

- AUST R complementary medicine applications.

Today’s full alert includes a summary of all key changes to the guidance as well as a comparison table of the 2022 list and the newly published 2023 list of COBs which outlines any changes or additions.

New COB Checklists are also published to accompany the updated guidance.

The TGA has published a new document on their website outlining the Mandatory Requirements to vary the Permissible Ingredients Determination. The publication of the document coincides with the publication of the new Therapeutic Goods (Permissible Ingredients - Information that Must Accompany Application for Variation) Determination 2023 on the Federal Register of Legislation (FRL), commencing 1 February 2023.

This means from today, 1 February 2023, there will be an updated process for making applications for a new (or changed) substance in the Permissible Ingredients Determination, including mandatory dossier requirements and data requirements (or justifications for not holding the data) in order to pass the preliminary assessment phase and proceed to the evaluation phase. The changes are an outcome of MMDR changes made to the Therapeutic Goods Act in 2018, and aim to standardise and improve efficiency of the application process. Existing applications will not be affected by the changes.

Compositional Guideline Templates: Four new templates are provided for specific types of substances.

NEW Guidance for Microorganisms (Probiotics and Postbiotics)

Additional guidance on the pre-market assessment of characterising microorganisms that are proposed to be used in either Listed medicines or Registered medicines that are to be used as probiotics and postbiotics. It is to be used in conjunction with the Mandatory requirements for an effective application to vary the Permissible Ingredients Determination (new substance application), or Mandatory requirements for an effective registered complementary medicine application.

The scope of the guidance covers microorganisms are whole and intact cells of bacteria and fungi (including yeasts) that are live or non-viable, but not other kinds of postbiotics, spores, etc.

Please read today's full alert for more information, background and how to contact CMA if challenges are encountered or changes needed. 

The TGA has published a consultation seeking feedback on proposed improvements to the product recalls process, which have been based on previous stakeholder feedback. The consultation, closing Monday 13 March, proposes significant changes to the recalls process. the attached alert outlines some potential benefits or concerns from an industry perspective.

Recalls are relevant to many stakeholders therefore the following stakeholders may wish to respond to some or all of the consultation questions:

- Sponsors

- Manufacturers

- Retailers

- Practitioners, Consumers 

Transition Reminder

Members are reminded that the end of the transition period for certain ingredient changes is approaching on 28 February 2023.

Some changes relate to pregnancy warnings, or allergen warnings, which are often subject to retail or consumer level recalls if the required statements are not included.

Vitamin B6

- maximum daily dose change from 200mg to 100 mg (adults);

- maximum daily dose change for children (depending on age group)

- warning statements on labels for products containing > 10 mg pyridoxine per MRDD.

Artemisinin containing herbs

- End of transition period to include a pregnancy warning for certain existing artemisinin containing ingredients.

Mollusc derived ingredients

- Updated allergen warning

These ingredients were subject to changes following the outcomes of the 2021-22 Permissible Ingredients Consultation. Please see CMA's 27 September 2022 tech alert, the TGA Final Decisions Document and the TGA Oct 2022 publication on Vitamin B6 for more information. 

Please note: Due to recent changes in the Advertising Code ‘health warnings’, members should also ensure, as a priority, that relevant advertisements (e.g. where an advertisement facilitates directly the purchase or other supply of a medicine; and the medicine is not available for physical inspection by a consumer prior to purchase or other supply)  have the required warnings.

A notice of final decisions has been published on the TGA website in relation to dichloromethane (also known as methylene chloride).

CMA is pleased to inform members that the Delegate has decided to vary the Interim Decisions to clarify the entry for dichloromethane in the Poisons Standard by including a new exemption for human therapeutic preparations in the Schedule 5 entry.

In our response to the original proposal and interim decision, CMA continued to seek alignment of the entry for dichloromethane in the Poisons Standard with the Determination, TGO 101 and ICH guideline Q3C (R8) for residual solvents, to ensure consistency of requirements across the regulatory framework.

Therefore, this final decision not only prevents the initially proposed total S10 ban on dichloromethane, it also resolves the issue of the Poisons Standard to-date not being aligned with other regulatory legislation. It prevents the unnecessary removal of complementary medicines from supply and assures the ongoing safe supply of the affected nutrient fractions and herbal extracts. It allows listed medicines with the affected nutrients and extracts to remain in legal supply, provided they remain compliant with the required cut-off limits in other regulatory requirements as described further in this alert.