We asked, You said, We did

The TGA sought feedback on the draft guidance Complying with the Unique Device Identification regulations for medical devices. The consultation principally sought feedback on:

• Relevance of the content
• Usability of the content
• Structure of the document
• Terminology used in the document
• Additional content that would benefit the reader. 

37 submissions were received, with most representing medical device sponsors and manufacturers. Other respondents includes industry peak bodies, registries, regulatory consultants and Issuing Agencies. No submissions were received from general practitioners, export-only Australian manufacturers, or consumers. 

Respondents provided wide-ranging comments and suggestions across all questions. Overall, the responses provided positive feedback on the document as well as many valuable comments and suggests for improving the usability and content of the document.

The TGA appreciates all the feedback and thanks all respondents. 

We have analysed all responses and the results have informed updates to the guidance document. In line with your strong feedback, changes made to the document include:

• Additional examples, use cases and images
• Further explanation for complex topics such as UDI Triggers and Unit of Use
• Additional appendices including Australian UDI Data Elements
• Inclusion of additional information for topics such as:
  • Medical devices incorporating software
  • Refurbished devices
  • Devices sold principally in retail premises
  • Capital equipment
  • In vitro diagnostic kits
  • Record keeping requirements
  • Single use devices
  • Spare parts, replacement parts and accessories
• Editorial changes. 

The guidance will be published on the UDI Hub on the TGA website once finalised. 

The Therapeutic Goods Administration (TGA) continually seeks out ways to improve the way we monitor and manage the impact of shortages and discontinuations in Australia. In late 2024, we asked for feedback on proposed changes to the medicine shortages and discontinuations regulatory framework to:

1. Improve TGA’s monitoring of medicine shortages by:
   1. Adding more critical non-prescription medicines to the list of reportable medicines - this would require pharmaceutical companies (‘sponsors’) of those medicines to report shortages and discontinuations to the TGA; and
   2. Updating the Therapeutic Goods Act 1989 to enable the TGA to request detailed supply information from sponsors when needed about any approved medicine, not just reportable medicines.
2. Require sponsors to provide 12 months’ notice to the TGA of a decision to permanently discontinue supply of any reportable medicine in Australia.

We received 39 submissions from a range of stakeholders, including the pharmaceutical industry, health professional and consumer organisations and government agencies.

Monitoring medicine shortages

There was extensive support for the TGA’s proposal to add the 23 non-prescription medicines identified in the consultation to the Reportable Medicines Determination, and to update the Therapeutic Goods Act 1989 to enable the TGA to request detailed supply information from sponsors about any approved medicine.

Respondents provided a range of views and suggestions, including:

• a majority view that the TGA’s proposals presented a balanced approach to improving medicine shortages monitoring without significant increase in regulatory burden
• acknowledgement from multiple industry respondents that the alternative option of making all registered non-prescription medicines reportable would result in significant regulatory burden
• requests for additional individual non-prescription medicines to be added to the list of reportable medicines
• recognition and support from respondents on the importance of regularly reviewing and updating the list of reportable medicines to ensure currency
• support for continued stakeholder engagement with the TGA about emerging medicine shortage issues and policy considerations.

Medicine discontinuations

Overall, the majority of respondents preferred the TGA’s proposal to mandate a uniform 12 months’ notice of a decision to permanently discontinue a reportable medicine (or as soon as practicable after the decision is made). 

The following range of views were received:

• the most support for introducing a uniform 12-month notice period for medicine discontinuations came from government, health professional and consumer organisations
• it was strongly recognised that the TGA proposal would make reporting obligations clearer for sponsors, but concerns were raised about sponsors’ ability to meet the TGA’s proposed 12-month notice requirement
• it was noted that the TGA’s proposed 12-month notice requirement was greater than discontinuation reporting requirements in other countries
• industry stakeholders noted the importance of maintaining the existing clause ‘or as soon as practicable after the decision is made’ for situations when sponsors are unable to provide 12 months’ notice of an upcoming discontinuation (e.g. due to unforeseen commercial factors)
• requests for flexibility in the timing of TGA publication of discontinuations, due to concerns about risks of stockpiling and wastage when patients change to alternative treatments
• concerns about situations where one product is replaced with another (e.g. resulting from product reformulations), and how they are currently reported and published as ‘discontinuations’, despite supply being maintained.

Thank you to everyone who provided feedback on the above proposals.

We have added 25 additional medicines to the legislative instrument that lists non-prescription reportable medicines. This means that sponsors of these medicines are required to report shortages and discontinuations to the TGA. The full list of reportable non-prescription medicines can be found at:

• Federal Register of Legislation - Therapeutic Goods (Reportable Medicines) Determination 2025

The TGA is still considering feedback on the proposals to update the Therapeutic Goods Act 1989 to enable the TGA to require detailed supply information from sponsors of any medicines, and requirements for reporting discontinuations.

The current exclusion of certain assistive technologies from regulation is increasingly unsuitable due to technological advancements, changing supply models, and growing customer demand. This consultation is required to ensure regulations for fit-for-purpose. We invited feedback from stakeholders on two (2) proposals to improve the regulation of assistive technologies:

1. The removal of the current exclusion
2. Exempt goods from the need to be included in the Australian Register of Therapeutic Goods (ARTG).

We received 25 submissions from a range of stakeholders, including manufacturers, sponsors, healthcare providers from the fields of assistive devices and allied health, hospitals, consumers, regulatory affairs consultants, and state and territory governments.

Proposal 1: Remove current exclusion

1. Stakeholders were asked whether they broadly agreed with the proposal to remove the current exclusion of “household and personal aid, or furniture and utensils”.

• The responses were mixed, the majority were for the removal of the exclusion. Disagreeing respondents consisted of industry representatives and assistive device providers.
• Respondents who agreed with the proposal suggested that TGA should have improved oversight of these products and that it would improve regulation of them. Some stakeholders said the removal may improve quality assurance of the products and ensure reporting of adverse events. Agreeing respondents noted that the growing complexity of the marketplace requires increased regulation.
• Those that disagreed suggested that the removal may lead to over-regulation and risk the incurrence of additional administrative costs and fees. This burden would ultimately fall on the customer. The disagreeing respondents were industry representatives.

2. Stakeholders were asked to list the financial impacts if the current exclusion were to be removed and what timeframe they would need to implement the proposed changes.

• There was a broad concern that the removal of the current exclusion will have a flow-on effect for the customer. Industry representatives suggested that a removal would increase compliance burden, time and money adjusting documentation and obtaining approvals.
• Respondents said that they would like to have a high quality, accessible, available in many languages source of information as guidance through this transition. There was also concern for a disproportionate impact on small business vendors from the respondents.
• There was broad support for a 1–2-year transition period for the proposal to be implemented. There was also suggestion for a phased approach. An institutional representative noted that the transition may take more than 2 years, if the changes were to be complex.

Proposal 2: Exempt goods from the need to be included in the Australian Register of Therapeutic Goods (ARTG)

1. Stakeholders were asked if they agreed with the proposal to exempt some assistive technologies.  

• Respondents suggested that “lower-risk” items to be exempt from ARTG inclusion. Examples provided included non-weight-bearing devices, those not customized to clients’ specifications, and devices commonly used in everyday settings.
• Industry representatives were concerned an exemption would exacerbate compliance burdens and have limited impact on reducing the cost of regulatory compliance. Exemptions – a couple of industry representatives noted – could impede on innovation within the sector and discourage producers from meeting quality standards.

2. Stakeholders were asked about what information regarding assistive technology they would like to be made public and how it should be organised.

• The responses were mixed. Respondents who wanted information about exempt products were from industry, consumer groups and allied health professionals. Stakeholders noted that devices, organisations, NDIS providers, schools and educational settings, hospitals should be on the list. Agreeing respondents also emphasised that the list should be clear and easy to follow to ensure compliance.
• A disagreeing respondent suggested that it may be “over-kill” since the exemption will likely apply to low-risk products.

• Stakeholders also said that information about exemptions should not be made publicly available where there is a risk of breaching privacy or confidentiality.

Boundaries

1. Stakeholders were asked about which boundary product they thought should be medicalised and which that should not.

• Several respondents suggested that boundary products should not be medicalised because it will restrict supply and are used mostly in every-day settings.
• Respondents suggested a risk-based assessment to decide on exemptions and medicalisation of products.

Further feedback

Stakeholders requested increased clarity and details on how these proposals might be implemented. They asked for more details on the specific issues TGA have experienced with regulating exempt medical devices and assistive technologies. Several stakeholders asked that the TGA conduct educational activities and improve website guidance to increase sponsor awareness and compliance with TGA regulatory requirements for assistive technologies.

Submissions, where permission has been granted, will be published soon.

We have reviewed the feedback provided for this consultation paper. Your feedback will inform internal discussions and further consultations with stakeholders. We will inform stakeholders about any further consultations or related policy updates.

From 23 September 2024 to 22 October 2024, we sought submissions from the public on scheduling proposals referred to the November 2024 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

We received a total of 34 submissions in response to the pre-meeting public notice for November 2024. The breakdown of the responses has been provided below:

For ASTODRIMER SODIUM, a total of 12 responses were received, 3 in opposition, 2 in partial support and 7 in full support of the proposed amendments.

For ATROPA BELLADONNA, a total of 6 responses were received, 1 in opposition, 1 in partial support and 4 in full support of the proposed amendments.

For ETHYLENE OXIDE, PROPYLENE OXIDE and EPICHLOROHYDRIN, a total of 2 responses were received and both were in full support of the proposed amendments. No response was received in opposition or partial support.

COMFREY a total of 6 responses were received, 1 in partial support and 5 in full support of the proposed amendments. No response was received in opposition.

PYRIDOXINE a total of 17 responses were received, 15 in opposition, 1 in partial support and 1 in full support of the proposed amendments.

The Delegate considered all submissions prior to making an interim decision on these proposals. The interim decisions on the proposed amendments to the Poisons Standard were published on 14 MARCH 2025.  

The TGA sought feedback on a consultation paper Clarifying and strengthening the regulation of Artificial Intelligence (AI) between 12 September 2024 to 20 October 2024. The consultation was part of the Australian Government’s Supporting Safe and Responsible AI Budget measure and included a number of proposals aimed at managing future risks and leveraging opportunities associated with the use of AI models and systems within, or as, therapeutic goods.

Specifically, we sought feedback regarding:

• potential changes to language, terminology and definitions within the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
• the appropriateness of the TGA’s existing regulatory approach and requirements for medical devices that are, or incorporate, AI
• risks and/or advantages of maintaining international harmonisation
• the appropriateness of currently excluded software under the Excluded Goods Determination 2018 (the Determination)
• public perception of what ‘transparency’ means in the context of AI technology and what measures might be put in place to address this issue
• education material and guidance needed to provide clarity.

Fifty-three (53) responses were received from a range of stakeholders from within the healthcare and therapeutic goods sectors, including members of consumer representative organisations, health professional peak bodies, government entities and the medical device industry, including sponsors and manufacturers (developers) of software.

Most stakeholders agreed that:

• the TGA’s existing risk and principles-based regulatory framework is flexible, robust and largely fit for purpose to meet the current and emerging risks associated with AI technology
• there is opportunity for amendments and improved guidance resources that will help improve stakeholder understanding by clarifying and strengthening the existing framework
• ongoing review and refinement of existing definitions or clarification through guidance should be undertaken in harmonisation with broader national and international activities to ensure clarity
• if future refinements are required, they should be informed by further consultation with stakeholders.

Stakeholder feedback identified areas for further review and public consultation including:

Definitions

The majority (91%) of stakeholders confirmed the TGA’s existing framework and technology-agnostic approach is robust and flexible to effectively regulate AI where it is, or is incorporated within, a therapeutic good. However, 78% of stakeholders from healthcare and therapeutic goods sectors commented that terminology in the Act and the Regulations, whilst generally understood by traditional medical device manufacturers, is not intuitive to developers within the software industry.

Specifically, stakeholders recommended further review and clarification of certain terminology and definitions including ‘manufacturer’, ‘sponsor’, and ‘supply’ to ensure clarity and alignment with other legislation and international frameworks. More broadly, stakeholders proposed the inclusion of terms such as ‘software’, ‘bias’, ‘AI drift’, ‘locked model’, ‘autonomous learning’, ‘substantial change’, ‘incorporates software’, and ‘programmed or programmable medical device’ to the legislation.

Stakeholders also requested guidance be developed to interpret these terms, to ensure clarity and resolve disparity with terminology used in other legislation and international frameworks. Feedback from the therapeutic goods industry further stated that any proposed clarifications or amendments should be made only where necessary and in alignment with international standards.

Roles and responsibilities

The majority (81%) of stakeholders agreed that a review of the definitions within the Act and subordinate legislation is required to clarify responsibility for the development, deployment, and use of AI models and systems. Stakeholders expressed concern that existing legislation does not clearly stipulate the responsibility for the outcomes of advanced AI technologies, including adaptive AI, where these outputs constitute an offence under the Act. Specifically, stakeholders recommended that where AI replaces human services or when the deployer is unaware of outputs that legal clarity be provided as to what constitutes an offence.

Medical device industry stakeholders noted clarity is required regarding regulatory responsibilities for activities unique to software and AI technologies. These activities include:

• supply through online marketplaces where products are hosted on overseas servers
• use of open-source software and datasets
• how to account for outputs of adaptive or generative AI models where the original deployer does not have oversight of the relevant output.

Health professionals strongly expressed views that the legal responsibility for the safety, quality, and performance of software, including AI, should be assigned to manufacturers and sponsors. Health professionals stated that their responsibility was to understand the risks, safe operation, ideal use cases, and how to verify the AI models and systems they choose to use within the context of their clinical practice.

Compliance

Stakeholders confirmed the use of AI products is already prevalent within the healthcare sector, driven by benefits including increased efficiency, improved patient health outcomes, cost reduction, improved accessibility and capability. However, there were issues associated with the use of these products, both observed and reported in responses received, including:

• a general lack of understanding of what products meet the definition of a medical device and are therefore regulated by the TGA
• inappropriate use of AI-enabled products due to a lack of understanding or misinformation about the intended purpose of these product.

The majority (78%) of stakeholders requested that the TGA continue to directly engage with the software sector to deliver improved education and guidance materials to help clarify existing regulatory obligations.

Classification rules

Most stakeholders (61%) indicated the current classification rules are largely appropriate for use in medical devices that are, or include, AI models or systems and immediate changes are not required.

Additionally, most stakeholders (76%) indicated a future review of the existing classification rules is needed for software based medical devices intended to provide a prediction or prognosis. Therapeutic goods industry stakeholders suggested these changes should only be initiated when more evidence is available regarding the use of these kinds of products, and at a time when other jurisdictions are considering a similar classification rule change.

Essential principles

Most stakeholders (64%) broadly agreed the existing essential principles for safety and performance remain appropriate for use in medical devices that are, or incorporate, AI. However, respondents indicated more information should be developed and disseminated to explain the TGA’s requirements with respect to:

• ongoing validation of adaptive and generative AI
• use of open datasets
• open-source software
• performance reporting in clinical settings
• labelling requirements
• instructions for use.

Regulation for specific AI types and subtypes

Members of the medical device industry expressed concern that regulating AI as a whole or as individual subsets will be challenging because of the variety and complexity associated with these technologies. These respondents indicated regulatory requirements should continue to be centred on risk factors (such as the severity of the condition a device is intended to treat, the intended user of the device, etc.) rather than specific technologies or subtypes of AI. Where definitions and clarity about AI types and subtypes are sought, stakeholders generally felt this would be better achieved through guidance rather than specific regulations.

Excluded software

Most respondents expressed that many of the current software exclusions remain appropriate. However, further guidance is needed to better support stakeholders with understanding the conditions of exclusion. However, 62% of consumer and health professional stakeholders expressed concern regarding the existing conditional exclusion for certain low-risk digital mental health tools. Particularly where these tools are supplied to consumers independent of clinician oversight and review.

Most (53%) respondents from across all stakeholder cohorts called for a more detailed review and ongoing monitoring of the conditional exclusions including digital scribes and consumer health products. Some members of the medical device industry cautioned changes to the conditional exclusions should avoid the regulating low-risk products and recommended proposed changes be the subject of future consultation.

Advertising and transparency

A consistent theme from stakeholders (71%) across all cohorts was the desire for access to more information about therapeutic goods and how they are assessed and approved by the TGA, including when accessing digital therapeutic goods through virtual and online environments.

Consumer and health professional stakeholders requested access to additional publicly available information including:

• the model and/or trade name(s) for ARTG included goods
• specific intended purpose or indications of the good
• whether the device is, or operates using, an AI model or system, and information about the datasets that have been used to train and test the AI
• greater transparency regarding updates and new versions to help assess whether the outputs of a product are likely to change as a result
• in-app or in-product notifications tied to risks the user should be aware of when using it.

Stakeholders acknowledged the utility the unique device identifier (UDI) system will offer to assist with transparency. However, access to information about all therapeutic goods, including software based medical devices may require further review of the Advertising Code and medical device labelling requirements.

Guidance

Most respondents (78%) from across all stakeholder cohorts noted that while many guidelines and standards relating to the regulation of therapeutic goods and provision of healthcare services exist, there are few resources explaining how they should be applied to emerging technologies including AI. Some members of the medical device industry acknowledged review of these resources and development of new standards and guidelines is currently underway.

These stakeholders also suggested a general review of the TGA website is required to improve accessibility, searchability, and software-related content generally. The majority of respondents (91%) requested the reinstation of specific content and landing pages for consumers and health professionals. Members of the medical device industry requested the development of more guidance and resources for AI-specific topics including explicit information about the technical requirements for different subtypes of AI. Stakeholders from the medical device industry also requested that guidance and information be made available through a range of mechanisms, including social media platforms.

Continuous change control for adaptive AI

Members of the medical device industry and health professionals noted continuously adapting AI models are likely to require constant monitoring and real time evaluation of performance to ensure the quality of system outputs do not degrade over time. These stakeholders also expressed that tailored AI models would likely need to be deployed by manufacturers to perform this rolling review of model performance.

Some voiced desire for clear guidance regarding what constitutes ‘significant change’ in the context of software as a medical device. These stakeholders also requested more information be developed to clarify the regulatory processes associated with assessing and approving changes in adaptive models and systems.

International harmonisation

The majority (95%) of stakeholders from across the therapeutic goods sector stated international harmonisation and engagement with comparable jurisdictions should be maintained as far as possible to minimise regulatory burden and disruption to supply of innovative devices. Some therapeutic goods industry stakeholders suggested that Australia should be responsive and reactive to developments in other comparable jurisdictions and the identification of specific risks with respect to AI, rather than proactive.

This consultation was undertaken under the Budget measure for Safe and Responsible AI and was intended to identify areas for improvement in the legislative framework to mitigate future risks and leverage opportunities associated with the use of AI within the therapeutic goods sector, including software as a medical device. The TGA has provided a report to the Australian Government to inform policy decisions that responds to the findings of the AI review.

The TGA sought feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes were intended to address the following issues:

1. Herbal ingredients with pregnancy contraindications and other toxic effects
2. Garcinia species, hydroxycitric acid, hydroxycitrate complex and salts, and risk of liver injury
3. Xanthium species
4. Phenoxyethanol
5. Clarification of hydration state for Rutoside.

A total of 9 submissions were received in response to this consultation. All submissions that gave permission to be published on the TGA website are available through the ‘View submitted responses’ link below.

The TGA received:

• 6 responses to the proposed changes for herbal ingredients with pregnancy contraindications and other toxic effects
• 4 responses to the proposed liver warning statement for Garcinia species and related ingredients
• 7 responses to the proposed removal of Xanthium species
• 6 responses to the proposed update to the requirements for phenoxyethanol
• 4 responses to the proposed update to clarify the requirements for Rutoside.

The responses varied in stance and recommendations. The feedback from professional medical groups was supportive of most of the proposals, however the majority of respondents from the complementary medicines industry only partially supported the proposals, with many suggesting rewording or clarification of the proposed warning statements and requirements. See the Final Decisions Document for details of issues raised by respondents and the TGA’s response.

The feedback and recommendations provided by respondents were taken into consideration in making the final decisions to amend the Permissible Ingredients Determination for the ingredients discussed in the consultation. The final changes incorporate variation compared to the original proposals.

The final changes will commence on 1 March 2025. A 12-month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2026.

From 26 July 2024 to 23 August 2024, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the March 2024 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written submission.

A total of 16 submissions were received through the consultation, 4 from individuals and 12 from organisations. A breakdown of the submissions can be found below.

CYTISINE: 5 submissions were received, 3 in full support, and 2 in partial support of the interim decision. 4 submissions provided a written component, 2 in support and 2 in partial support.

DEXTROMETHORPHAN: 4 submissions were received, 3 in full support, and 1 in partial support of the interim decision. Of these, 3 provided a written component, 2 written submissions in support, and 1 in partial support.

DIHYDROCODEINE: 7 submissions were received, 2 in partial support and 5 in opposition of the interim decision. All the 7 submissions included a written component.  

ETHYLMORPHINE: 2 submissions were received and both were in opposition of the interim decision. All the 6 submissions included a written component.  

OXYTETRACYCLINE: 1 submission was received which was in opposition of the interim decision and included a written component.

TRANEXAMIC ACID: 4 submissions were received and all in full support of the interim decision. Of these, 3 provided a written component.

ETHYL LACTYL RETINOATE: 6 submissions were received, 2 in full support and 4 were in opposition of the interim decision. All the 6 submissions included a written component.  

NICLOSAMIDE; No submissions were received.

The Delegates considered all submissions prior to making their final decision. The final decisions on the proposed amendments to the Poisons Standard were published on 27 September 2024.

Final decisions on DIHYDROCODEINE and ETHYL LACTYL RETINOATE have been deferred while the submissions received from the consultation on interim decisions on these two substances are further considered.

 

The Therapeutic Goods Administration (TGA) undertook a public consultation relating to a proposal to introduce legislating regulatory categories for some boundary and combination products. The consultation sought feedback on whether:

• legislating some products to formally declare their regulatory category (e.g., medical device, medicine, or other therapeutic good), would improve clarity for stakeholders
• and if so, whether a transition period of five years would be sufficient for sponsors with affected ARTG entries.

The following products were considered in this consultation:

• Head and body lice products for humans
• Moisturisers and emollients
• Toothpastes (dentifrices)
• Products generated by ozone generators
• Weight loss treatments – ingested
• Vascular Access Device (VAD) locking solutions and
• Pre-filled saline flush syringes (PFSFS)

We also asked for feedback about the classification level for VAD locking solutions and PFSFS.

Thirty-four responses were submitted by a range of stakeholders including medical device manufacturers, sponsors, medical device industry peak bodies, State and Territory Health Departments, regulatory affairs consultants, health professionals and consumers. Most respondents represented medical device industry and medical device peak bodies, followed by government entities, regulatory affairs consultants, health professionals, and consumer.

Legislating regulatory categories for some boundary and combination products

The feedback overall indicated that legislating regulatory categories of products such as head and body lice products for humans, moisturisers and emollients, toothpastes (dentifrices), products generated by ozone generators, and ingested weight loss treatment as mentioned in the consultation paper would provide additional clarity on the regulatory requirements for these products. Feedback confirmed that this proposed change may assist manufacturers to meet the necessary regulatory requirements and potentially facilitate faster assessment of applications by the TGA for products to be included on the Australian Register of Therapeutic Goods (ARTG).

Those who did not support the proposal stated that legislating the regulatory categories would cause further confusion as a legislative approach would be restrictive in situations where it is difficult to determine the primary mode of action of the product. They said that often the TGA’s and the sponsor’s interpretation of ‘principle intended action’, ‘active ingredients’, and ‘active ingredient at unscheduled levels’ i.e. lower than what is mentioned in the Poisons Standard, do not align. It was also stated that further clarification is needed on products that have both pharmacological and physical mode of action, and products for cosmetic use.

It was suggested that if the proposal was implemented, that the TGA give consideration, where required, to ensure continuity of product supply in the Australian market while industry work towards transitioning any products. Most respondents supported a five-year transition period for affected ARTG entries and noted that this would allow sufficient time for the manufacturers to make necessary adjustments.

Sponsors also said they should be able to seek targeted guidance from the TGA including steps to help them correctly categorise their product. It was also highlighted that in some cases, manufacturers may choose not to transition affected products (ie: cease supply)

Vascular Access Device locking solutions and pre-filled saline flush syringes

Feedback received about the regulatory category and classification for VAD locking solutions and PFSFS was mixed. Some stakeholders raised concerns about these products being regulated as a medical device when they contain a medicine, and others raised concerns about the risk classification.

There were suggestions to regulate these products as both a medicine and a medical device, whereby the medicine component should be assessed as per medicine regulations with a requirement to provide pharmacokinetic data on local and systemic effects including antimicrobial resistance (AMR), noting that even a subtherapeutic dose of antibiotics can increase the risk of AMR. It was highlighted that products containing saline with or without added substances in general should be regulated to the highest available standards as storage and sterility of these products is very important.

It was noted that the saline in PFSFS, even if intended for flushing, is not aspirated in most cases, and often enters the bloodstream. Some respondents also said the concept of irrigation does not apply to these products as there is no drainage step following introduction of the saline. They said saline has an effect both locally and systemically through interaction with the blood and repeated doses, particularly in infants and patients with renal failure can have physiological effects. Other respondents claimed that the saline in these products when sold separately should be regulated as a medicine irrespective of the presence of added substances and argued that this qualifies these products to be regulated at a higher-risk classification.

Feedback in favour of the proposal stated that the regulatory categories and classification level mentioned in the consultation paper makes sense, is easy to understand, and provides needed clarity on the regulatory category of these products.

If regulatory changes were introduced, a five-year transition period for the effected products was supported by the majority of stakeholders as sufficient for manufacturers to adapt to any new requirements. However, it was noted that the ease of transition would depend on the size (small or large) and resources of the manufacturers. It was also suggested that the TGA could consider a shorter transition period for products containing antimicrobial and anticoagulants due to the higher risk associated with these products.

Other products suggested as needing additional clarity

A number of stakeholders also suggested other boundary and combination products that need additional clarity in relation to their regulatory categories, such as:

• Bone cement and other implantable products embedded with antimicrobials
• Alcohol swabs
• Lubricants and gels (eye lubricants, vaginal gels ultrasound gels, personal lubricants)
• Products that change the pH in a lumen, CO2 absorbers
• Wart, corn, and callus removal products
• Topical nail treatment solutions with antibacterial or antifungal ingredients
• Ear wax softener
• Saline nasal solutions (hypertonic, hypotonic, isotonic)
• Eye drops (hypertonic), and medicated artificial tears
• Dietary supplements
• Cosmeceuticals
• Homeopathic products
• Products used to cleanse dentures such as dental cleansing solutions and brushes for cleaning dentures.

As suggested by some stakeholders in their consultation feedback, the TGA organised targeted workshops to discuss the consultation paper and provide a forum to further explore comments made by respondents

Feedback from the workshops

Feedback from the majority of stakeholders from the medical device industry, health professionals and government entities supported legislating regulatory categories of head and body lice products, moisturisers and emollients, toothpastes, products generated by ozone generators and ingested weight loss treatment. It was also suggested that the TGA should:

• ensure alignment with other comparable overseas jurisdictions,
• provide risk-based justifications for any changes to a product’s regulatory category,
• provide more examples of these products through the published example list within the guidance forboundary and combination products,
• provide clearer guidance and interpretation of ‘primary mode of action’ and
• consider more stringent regulation of medical devices incorporating antimicrobials due to their potential to cause AMR.

Feedback on VAD locking solutions and PFSFS was mixed, with some stakeholders suggesting these products should be regulated as medicines, and others suggesting these products should be regulated as a medical device. Feedback was also divided on the risk classification of these products with some stakeholders suggesting these products to be low risk while others considered them to be high-risk.

We have reviewed the feedback received through the consultation responses and targeted workshops. The TGA is considering the feedback and may undertake further targeted consultations to finalise any policy positions before seeking Government consideration. We will inform stakeholders of the outcomes of the Government’s consideration including any changes to the regulatory categories or risk classification.

In July 2024, the TGA undertook a public consultation on establishing a model that more accurately estimates how much sunscreen Australians are exposed to on a regular basis. The model was proposed to enable the TGA to calculate the safe concentration of ingredients in sunscreens based on Australian conditions and the latest scientific information.

The consultation included 3 proposed options:

Option 1: Australian Sunscreen Exposure Model (ASEM)

Option 2: Scientific Committee on Consumer Safety (SCCS) exposure model

Option 3: Status quo

A total of 28 submissions were received from the therapeutic goods and cosmetic industry (industry organisations, sponsors, and manufacturers), non-profit organisations, universities, government organisations, health professional organisations, and individuals.

Submissions that consented to being published are available through the ‘View submitted responses’ link below. 

The TGA would like to thank all respondents for their submissions and extend our appreciation for the feedback received. Key points have been summarised below.

Preferred option

There was broad in-principle support for the adoption of the ASEM (option 1) for estimating sunscreen exposure when conducting sunscreen ingredient risk assessments. All respondents did not support Option 3 as the preferred option, and only 3 respondents (primarily European cosmetic industry associations) preferred Option 2. Some industry respondents did not endorse all the elements of the ASEM proposal and recommended suggestions for technical changes to utilise the ASEM more flexibly and reduce elements of the exposure calculations..

Importance of consistency of regulatory assessments and outcomes

Industry respondents emphasized the need for innovators and manufacturers of sunscreen ingredients to have confidence that the data they generate is consistent across all sunscreen regulators. One response highlighted that the calculations and assumptions for the ASEM formula require the same safety data inputs as the SCCS exposure model. This consistency supports innovators of new ingredients by allowing them to provide data that meets the requirements of different agencies.

Some respondents also commented on the Margin of Safety (MOS) calculations presented for the ASEM, noting that it generally produces congruent results, which increases confidence in their reliability. In contrast, they pointed out that the way dermal absorption data is presented can significantly affect the MOS calculations (up to 5-fold) in the SCCS exposure model.

The TGA notes that the ASEM, and the highest estimated exposure value, provides the greatest regulatory consistency for risk assessments compared to the other options proposed in the consultation paper. This consistency can better support innovation and development of sunscreen ingredients. However, the ASEM can be capable of being flexible, accommodating for different product types if required which was also identified as important by some respondents.

Flexibility of risk assessments using the ASEM

Multiple industry respondents recommended that flexibility should be available when utilising the ASEM in the safety assessment of sunscreens designed for specific product types such, such as facial sunscreens, which are used primarily for the face unlike general primary sunscreens. One respondent noted the use of these products is consistent with Scenario 1 (indoor worker) presented in the consultation paper, and these products are packaged in smaller volumes.

The TGA acknowledges the merit in utilising the ASEM tool to consider a usage scenario for sunscreens that are not intended for general use. Further consideration will be given to establishing a standardised exposure assumptions to be included in future guidance, and what risk management and presentation requirements may be needed to ensure such products are used as intended.

Sunscreen application rate of 2 mg/cm² used in the ASEM

The majority of respondents agreed with the calculations and assumptions used in the ASEM formula, which includes the application rate of 2 mg/cm² that is required to achieve the labelled SPF rating.

Some industry respondents suggested that the 2 mg/cm² application rate does not reflect real-world consumer behaviour, highlighting that consumers typically apply sunscreen at lower rates. Two of these respondents recommended 1 mg/cm² be used as the application rate. These respondents quoted five studies, including 3 Australian studies already discussed in the consultation paper, and 2 older European studies (conducted outside Australia), highlighting the median or mean application were less than 2 mg/cm².

The consultation paper emphasized that one of the guiding principles was to ensure the adopted model accounts for correct usage directions for effective sun protection and this will not be achieved with application rates less than 2 mg/cm². Moreover, the ASEM assumptions were constructed to reflect the higher end of sunscreen usage in Australia, rather than the average Australian’s usage. This approach was taken to ensure that the risk assessments for sunscreen ingredients, when based on the highest usage scenarios, will also guarantee safety for lower usage cases where less of the ingredient may be applied to the skin.

The TGA acknowledges that not all consumers apply sunscreen at the thickness to achieve the labelled SPF; however, the same Australian studies quoted, and discussed in the consultation paper, support that there are Australians that would apply at 2 mg/cm² or more. The European studies quoted are conducted outside of Australia, and may not reflect the unique conditions and practices in Australia today for the reasons described in depth in the consultation paper. An application rate of 2mg/cm² is needed to cater for Australians who use sunscreen at the application rate of 2mg/cm² and those that use less, to ensure that sunscreen ingredients are both safe and effective when used as directed.

Clarification of sunscreen exposure calculations for the ‘highest estimated daily exposure’

One respondent supported the ASEM if the TGA seeks to calculate the upper band of annual average daily sunscreen exposure in the Australian population, noting the ASEM offers a plausible and defensible measure, based on current evidence. However, this respondent disagreed that the ASEM calculates the maximum dose of sunscreen that could be applied in one day, as it averages exposure over the course of a year based on weekly patterns, underestimating the potential maximum exposure in a single day.

The TGA wishes to clarify that the ASEM calculates the upper band of annual average daily sunscreen exposure in the Australian population, based on current Australian evidence and guidelines. Risk assessments for sunscreen ingredients typically focus on long-term exposure, however, any acute toxicity concerns are still considered in the risk assessment, and this would still utilise the maximum expected dose that could be applied in one day for a sunscreen used for whole-body application (140 mL).

Some Australians may use more sunscreen than proposed in some scenarios

One respondent recommended that the TGA increase the duration from 26 days to 52 days for Scenario 6 to account for the lifestyle of residents in beach-side communities in northern Australia. Another respondent noted that in high-performance sports, there is often a deliberate strategy of training during the hottest part of the day, when UV exposure is likely to be high. Further, the culture regarding the use or non-use of sun-smart clothing varies between different sports. For example, some sports, such as beach volleyball and canoeing or rowing, involve a high degree of UV exposure with minimal sun-smart clothing.

The highest average daily sunscreen exposures as established by the ASEM is 673 mg/kg bw/day or 336 cm²/kg bw/day which broadly covers the majority of different scenarios and populations. As an example, if the duration for Scenario 6 is extended from 26 days to 52 days as suggested, the highest average daily sunscreen exposure for adults across a year (i.e. Scenario 4 + 6) would be 408 mg/kg bw/day or 204 cm²/kg bw/day, which is still less than 673 mg/kg bw/day or 336 cm²/kg bw/day. As such, the 673 mg/kg bw/day or 336 cm²/kg bw/day exposure values would still ensure safety of ingredients for these circumstances.

Exposure assumptions for toddlers

Some industry respondents supported the ASEM scenarios but had concerns about the assumptions made in establishing the highest estimated average daily sunscreen exposure for toddlers aged 1-2 in Scenarios 3. These respondents suggested that toddlers would not have enough sun exposure requiring 3 applications of sunscreen a day (as per Scenario 3) due to typical daily schedules that include naps, eating, baths and indoor play. Instead, they suggested 1-2 applications of sunscreen daily were more realistic.

As discussed in the consultation paper, 3 sunscreen applications per day for Scenario 3 was derived from Australian research reporting on actual sunscreen practices followed by 1,189 Australian SunSmart early childhood centres, surveyed in the 2018 National Early Childhood Sun Protection Policy and Practice Survey. It should also be noted that the study revealed a proportion of services (ranging from 4-20% across Australia) also applied sunscreens 4 times a day, however this frequency was not utilised in Scenario 3 as it would likely result in an overestimation of majority practice. The calculations used in the ASEM were based on empirical evidence rather than assumptions relating to periods of daily sun exposure or generalised routines. Additionally, sunscreen application frequency does not necessarily correlate with total time exposed to the sun i.e. smaller individual time periods of sun exposure when the UV index is 3 or above (which can be year-round in parts of Australia) may necessitate multiple sunscreen applications for each period of sun exposure.

Some respondents expressed concerns about the assumptions made in establishing the highest estimated average daily sunscreen exposure in Scenario 5, suggesting that one day a weekend may not sufficiently reflect the highest use case and that sun protective clothing portrays recommended behaviour rather than what may be observed. The TGA appreciates that the perception, or reality, may differ from the assumptions of the ASEM scenarios, as they are also designed to account for Australian recommendations and public health messaging rather than solely habits and practices. This provides a standardised approach to ensure regulatory certainty. The currently proposed highest estimated average daily sunscreen exposure is based on a high use situation in toddlers (annually) which provides a conservative estimate that is sufficient to cover for variability in sunscreen use among different population groups. The TGA observes that even slight modifications to Scenario 5 would not have a significant impact on the overall exposure values, as Scenario 3 (which already accounts for short clothing and 3 application per day across 240 days) constitutes the predominant exposure for toddlers annually.

Considering the reasons above, and that the majority of respondents agreed with the highest estimated average daily sunscreen exposure calculations, ASEM assumptions and ASEM scenarios, the TGA has maintained the overall exposure estimates for the Scenarios.

Flexibility of the ASEM compared with the SCCS

One respondent commented that the ASEM is a good model with clear rational and accurately reflects consumer use of sunscreens. However, they preferred the SCCS model (Option 2), suggesting it is more flexible than the ASEM. They assumed the ASEM would be legislated and could not be updated if scientific information changes, potentially making the methods used obsolete, unlike the SCCS model, which is provided as guidance.

The TGA wishes to clarify that, as stated in the consultation paper, the exposure calculations derived from the ASEM will be included in the Australian Regulatory Guidelines for Sunscreens not legislation. The ASEM can also be flexible to accommodate for new usage scenario (as described above for facial sunscreen products).

Weather assumption used in ASEM scenarios

Four respondents recommended that the TGA consider extreme and/or above-average temperatures when estimating the days sunscreens are being used in Scenarios 5 and 6. These respondents noted that most outdoor activity occurs during the winter months in northern Australia, while acknowledging the ASEM calculations may not change.

While the exposure calculations were calculated for one day each weekend over a 6-month period from October to April, a similar time period may be considered for other regions in winter months due to less extreme weather. As noted, this amendment would not alter the ASEM calculations.

Barriers to trade

Some industry respondents raised concerns that Australian-specific assessments could create trade barriers for European products. Different allowable concentrations in various countries may impact the supply of certain ingredients. These respondents emphasised the need to ensure a sufficient range of sunscreen active ingredients to formulate very high SPF products without compromising safety.

The consultation paper highlighted the differences between Australian environmental and cultural conditions and the regulatory framework for sunscreens compared to Europe. It stressed the importance of having an assessment process tailored to Australia's needs. Given that Australia has the highest incidence of skin cancer in the world, sunscreens designed primarily for UV protection are regulated as therapeutic goods with different compliance standards, unlike some sunscreens overseas that may be regulated as cosmetics. These differences can affect conclusions about the safety of ingredients, including approval of higher permitted concentrations in Australia compared to other countries. In contrast, alignment of international assessments may sometimes result in reduced availability of safe sunscreen ingredients in Australia. To ensure safe sunscreen active ingredients are not restricted from being used in Australian products, the TGA makes regulatory decisions following a careful analysis of the latest scientific evidence, tailored to Australia's distinct environmental conditions, health requirements, and regulatory framework.

Clarity on preferred method used when dermal absorption is reported as both proportion (%) and absolute amount (µg/cm²⁾.

Several respondents sought clarification on which method of the ASEM will be used when dermal absorption data is provided as both a % and µg/cm². These respondents emphasised the need for clear rules to determine which method will be used.

The choice of dermal absorption factor and method of calculation (i.e. Method 1 vs Method 2) depends on the type and quality of the data available for establishing the dermal absorption potential of the ingredient under consideration. In general, there is no preference for use of Method 1 or Method 2 as the ASEM approach results in the same risk quantification (i.e. same MoS values) irrespective of whether dermal absorption is quantified in μg/cm² (Method 2) or as a percentage (Method 1) when the test formulation is applied at a thickness of 2 mg/cm² in the dermal absorption study (compliant with OECD 428 – Guideline for Skin Absorption: in vitro method).

Dermal absorption studies (compliant with OECD 428) typically express results as both an absolute amount (i.e. µg/cm²) and a relative amount (percentage) and stipulate an application rate of 1-5 mg/cm² to mimic realistic human exposure. While 2 mg/cm² is the thickness of applied sunscreen needed to achieve the labelled SPF rating, studies often apply the test formulation at 3, 4, or 5 mg/cm² instead. The SCCS notes for guidance for testing of cosmetic ingredients (12^th Rev) also state that in vitro measurements using less than 2 mg/cm² are not technically feasible. The SCCS guidance on basic criteria for the in vitro assessment of dermal absorption recommends a 2-5 mg/cm² dose of test formulation. This can cause variability in the risk quantification (i.e. MoS calculation) between Method 1 and 2 since the reported absolute amount absorbed will be a different percent of 3, 4, or 5 mg/cm² application rate versus that of a 2 mg/cm² application (as highlighted in Attachment 3 of the consultation paper).

Where an application rate greater than 2 mg/cm² is used in the dermal absorption study, the absolute amount (µg/cm²) may be used when calculating the systemic exposure for risk assessments in order to minimise this variability. This is particularly important since it is known that the efficiency of absorption may remain the same or change as the concentration on the skin increases for some chemicals. For chemicals that penetrate the skin rapidly, the total amount of chemical absorbed increases as the dosage increases. Conversely, for chemicals that penetrate very slowly, the rate of penetration and the surface area exposed will have a greater influence on the systemic absorption dose than the extent of dermal deposition.

Since the efficacy of sunscreen ingredients relies predominantly on their ability to persist on the skin (including the top layers of the skin), they are likely to penetrate very slowly (or ideally not penetrate). Suggesting that the total amount of chemical systemically absorbed may not be proportional to the dermal dose/deposition. Hence using the dermal absorption factor expressed as a proportion (i.e. %) may not be appropriate for some sunscreen ingredients. 

Clarity on use of annual average instead of lifetime average for daily dose calculations

Some respondents queried why an annual average daily dose was calculated instead of a lifetime average daily dose in the ASEM. These respondents did not express a preference for either calculation method. Estimating sunscreen use is highly complex, as sunscreen use patterns vary among individuals based on several factors as discussed in detail in the consultation paper. A yearly model was utilised to account for the variability across weekday and weekend activity, and annual weather conditions. It is important to note, that while the ASEM calculates average daily exposure based on an annual sunscreen use pattern, this still allows for risk assessments that ensure safety of long-term sunscreen use throughout life.

We have considered all of the submissions and diverse stakeholder views, and in response, the TGA will adopt the ASEM and the highest estimated average daily sunscreen exposure values (Option 1). This will be utilised for assessments for ingredients in general sunscreens that can be used for the whole body and different ages. However, to address stakeholder feedback to increase flexibility, the ASEM tool will be utilised to allow future risk assessments to consider different product types such as face-only sunscreens. The Australian Regulatory Guidelines for Sunscreens will be updated accordingly, with guidance for future new sunscreen ingredient applications.

The ASEM significantly enhances Australia's ability to conduct safety reviews of sunscreen ingredients. We are now using it to finalise a literature review of some common sunscreen active ingredients, following international developments that have led to legislative changes for ingredients that can absorb into the body. Additionally, setting an acceptable regulatory limit for benzophenone (a degradant in sunscreens containing octocrylene) was deferred in December 2023, pending consideration of an appropriate sunscreen exposure model. The ASEM will now be utilised in assessing the risk of these active ingredients and benzophenone. Our review will consider the latest scientific evidence and use the ASEM to ensure these ingredients are safe for use at permitted concentrations. After completing our review, we will take any necessary regulatory measures and undertake public consultation as per TGA’s standard processes.

We asked for feedback on proposed updates to rules for medicine labels to:

1. Make sure that quantities of active ingredients in injectable medicines intended for electrolyte replacement are clear on labels and in units important to health professionals.
2. Make sure that clear instructions on how to prepare and store certain injectable medicines administered by healthcare professionals is available in the appropriate format.
3. Give consumers more information about large solid oral dosage forms on labels of listed medicines.

We received 60 submissions in response to this consultation. Respondents had a range of opinions about the 3 parts of the consultation.

Most respondents supported the proposed changes for expressing quantities of active ingredients in injectable medicines intended for electrolyte replacement. Some respondents suggested improvements to the proposed requirements.

We received mixed feedback about proposals for instructions for preparation of injectable medicines administered by healthcare professionals. Many respondents, including health professionals, raised concerns about electronic access to information when preparing medicines. For example, there may be situations where there is poor internet connectivity at time of administration, or where a QR code reader is not available or permitted.

We received a range of feedback about the proposed requirements for large solid oral dosage forms. Many respondents gave us feedback about the proposed dosage form sizes that would need information on the label.

We appreciate all the feedback we received and considered all responses before deciding on next steps.

Active ingredients quantities in injectable medicines intended for electrolyte replacement

We made changes to Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) to make medicine labels clearer for health professionals.

For injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less):

• The label must now express potassium chloride quantity in millimoles. Labels must also include the quantity of potassium chloride in weight except in certain circumstances.
• The label must continue to express the quantity of other active ingredients in weight. The label must also include the quantity in millimoles of each active ingredient.

We also used the feedback to make minor changes to the proposed requirements presented in the consultation paper. This gives more clarity to medicine sponsors about requirements for small containers containing potassium chloride.

Medicine sponsors have time to update labels with medicines manufactured or imported from 1 December 2026 having to comply with the updated requirements.

We have included guidance about the new requirements in Labelling medicines to comply with TGO 91 and TGO 92.

Instructions for preparation of injectable products administered by healthcare professionals

In response to concerns about access to electronic information at the time of administration, we are maintaining the current arrangement of requiring instructions for preparation of injectable medicines to be printed either on the label or as a package insert.  QR codes can be used but cannot replace printed information about how to prepare these medicines at this time. We have therefore not changed the requirements in TGO 91 about instructions for preparation.

However, we have updated the package insert template and Labelling medicines to comply with TGO 91 and TGO 92 to give more clarity to medicine sponsors about providing instructions for preparation.

We encourage medicine sponsors to supply electronic medicine information through machine readable codes on the label and other mechanisms (for example, QR codes), in addition to printed instructions for preparation.

Despite our decision at this time, we will reconsider the replacement of physical instructions for preparation in the future to support environmental benefits, technological advances, and international alignment. For example, we intend to seek feedback on updated proposals when we conduct a broader review of TGO 91 and TGO 92 in 2025.

Information on listed medicines about large solid oral dosage forms intended to be swallowed whole

We are still considering the feedback about proposed changes to TGO 92 to improve information about large oral dosage forms. We will inform stakeholders as soon as we decide on the changes to TGO 92.

More information about changes to medicine labels

Changes to medicine labels take time. We allow medicine sponsors time to update labels to support the medicine’s availability in the community. New labels appear gradually as new stock is distributed, and existing stock is used up. Medicines with new labels may be available at the same time as medicines with older labels.

For more information about the changes see:

• Updates to requirements and guidance for labels of injectable medicines

 

 

The Therapeutic Goods Administration (TGA) undertook a public consultation related to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs). The primary objective of the proposed changes were to improve the transparency, identification and awareness of products in these categories; thereby supporting faster action if safety concerns were identified.

There is widespread misunderstanding and confusion about what regulatory requirements manufacturers and sponsors need to meet if they supply exempt medical devices. Sponsors of these categories of goods are still subject to, and must meet, relevant regulatory obligations and they are subject to oversight by the TGA.

The consultation sought feedback from stakeholders on three (3) proposals to improve the regulation of exempt medical devices and exempt OTGs:

1. Require notification of supply to the TGA
2. Publish information about supply on the TGA website
3. Provision of information and samples of products to the TGA.

Thirty-eight (38) responses were submitted by a range of stakeholders, including manufacturers, sponsors, healthcare providers from the fields of dentistry and allied health, hospitals, consumers, regulatory affairs consultants, and state and territory governments. 

Proposal 1: Require notification of supply to the TGA
We asked stakeholders for feedback on the proposal to require notification of supply from sponsors of certain exempt medical devices and exempt OTGs as per Appendix A of the consultation paper.

The responses were mixed, with half supporting this proposal and the other half not supportive of any change. Respondents who agreed with this proposal suggested that it would improve the TGA’s oversight and monitoring of these products. Some stakeholders clarified they would be supportive of this proposal if multiple products could be submitted under one notification. Those that disagreed suggested that notifications of supply would increase costs and regulatory burden without increasing patient safety. Industry and healthcare providers said the current regulatory framework is sufficient, without introducing notifications of supply.

We also asked stakeholders which exempt devices and exempt OTGs should require notification of supply and what information should be provided in these notifications. There was broad support to require notifications for exempt OTGs, exempt clinical decision support software, and exempt medical devices manufactured by healthcare providers. 

Most stakeholders agreed that notifications of supply should include contact information about the sponsor (e.g. name and postal address) and details about the exempt devices and exempt OTGs (e.g. product description or intended purpose, kind of device or OTG). 

Proposal 2: Publish information about products being supplied
We asked stakeholders for feedback on the proposal to publish information about the notifications of supply of exempt devices and exempt OTGs on the TGA website. 

Most respondents agreed with the proposal to publish this information. Stakeholders supporting this proposal advised that publishing this information would support both patients and healthcare providers to make informed decisions about using exempt devices and exempt OTGs. They also suggested that publishing this information would increase transparency and accountability for manufacturers and sponsors. 

Stakeholders who disagreed with this proposal advised that consumers should always be encouraged to contact the healthcare provider in the first instance for any issues with the product. They also noted that the exempt products they supply do not have sufficient risk associated with them to necessitate the requirement for notifications.

It was also noted that, for OTGs, sponsor contact information is already on packaging, however, this does not provide clarity for the TGA if there are any problems or issues with the product – ie: the TGA is not able to contact the sponsor/manufacturer.

Stakeholders also indicated that information about exemptions should not be made publicly available where there is a risk of breaching privacy or confidentiality. (Note that “supply” in this consultation refers to an organisation that distributes a product – it does not refer to each individual instance of supplying a product to a particular consumer or purchaser). 

Proposal 3: Provision of information and samples to TGA 
We asked stakeholders for feedback on proposals to require sponsors to provide information about exempt devices and exempt OTGs and product samples to the TGA upon request. 

Most respondents agreed that sponsors should be required to give additional information and provide samples to the TGA upon request. Stakeholders said information requests should be limited to requests for information that sponsors or manufacturers are ordinarily required to have available to meet their regulatory requirements (eg: evidence of compliance with Essential Principles, logs of adverse events etc). Some stakeholders noted that the cost of providing product samples to the TGA for exempt personalised medical devices may be prohibitive and would not be suitable for exempt devices imported for personal use.

Further feedback
Stakeholders requested increased clarity and details on how these proposals might be implemented by the TGA. They asked for more details on the specific issues the TGA has experienced with regulating exempt medical devices and exempt OTGs. Several stakeholders asked that the TGA conduct educational activities and improve website guidance to increase sponsor awareness and compliance with the TGA’s regulatory requirements for exempt devices and exempt OTGs.

As suggested by some stakeholders through consultation feedback, the TGA conducted targeted workshops to further discuss topics related to the regulation of exempt devices and OTGs mentioned in this consultation paper. 

Targeted stakeholder workshop
The TGA organised a targeted stakeholder workshop in October 2024 to discuss outcomes of the public consultation, provide and seek clarification on some of the issues raised and seek further feedback. Thirty-nine (39) stakeholders attended including sponsors, industry peak bodies, dental and allied health professionals and regulatory affairs consultants. Most attendees had provided responses to the public consultation.

Feedback from the workshops showed that most workshop participants disagreed with the TGA collecting and publishing information on exempt devices and OTGs (proposals 1 and 2). Slightly more than half of the workshop participants disagreed with providing information and samples to the TGA upon request (proposal 3).

We asked stakeholders for feedback on the following new proposals for improving regulation of exempt devices and OTGs:

• Educational outreach activities to raise sponsor awareness of their regulatory obligations.
• Changing terminology for ‘exempt’ devices and OTGs that have notification requirements to improve regulatory clarity for stakeholders.
• Requiring adverse event reporting for exempt devices and OTGs.
• Amending mandatory periodic reporting requirements for exempt devices and OTGs to reduce regulatory burden.
• Using the Medical Devices Vigilance Program (MDVP) for certain exempt devices and OTGs.
• Investigating compliance monitoring and an associated resourcing fee model.

Stakeholders generally agreed with these new proposals, with some exceptions.

When asked if stakeholders agreed with mandatory periodic adverse event reporting for patient safety, they were generally supportive. However, when asked if they supported mandatory periodic adverse event reporting for their specific sector, they were less supportive. Slightly more respondents supported mandatory periodic adverse event reporting for exempt dental / orthopaedic devices made by healthcare professionals and exempt disinfectants, compared to custom made medical devices, low volume patient matched medical devices, exempt Clinical Decision Support Systems, tampons and menstrual cups. 

When asked if stakeholders supported using the Medical Device Vigilance Program (MDVP) for certain exempt devices and OTGs, some stakeholders were unfamiliar with what the MDVP was, whilst others were uncertain as to how the MDVP would be applied to their exempt product. A stakeholder noted that the MDVP would be a useful tool in lieu of periodic reporting. 

The TGA also held targeted discussions with the Advisory Committee on Medical Devices, the Women’s Health Product Working Group and the Medical Devices Consumer Working Group. These groups generally support the proposals for improved traceability, transparency and accountability for exempt goods.

Based on the feedback provided, we will continue to convene further targeted consultations with stakeholders in 2025 about the proposals.

We undertook a public consultation related to instructions for use (IFU) for medical devices. We asked for your feedback on how IFU are provided and whether these should be made available in more flexible formats.

The consultation was hosted on the TGA Consultation Hub and was open for feedback from 15 April 2024 to 4 June 2024. Below is a summary of feedback received for the consultation paper. 

One hundred and eight (108) responses were received from stakeholders including State and Territory health entities, health professionals, healthcare peak bodies, healthcare institutes, regulatory affairs consultants, consumers, and consumers peak bodies with most responses from medical device manufacturers and sponsors.

The feedback overall indicated support to change the requirements for providing IFU for medical devices, including allowing electronic instructions for use (eIFU) to be provided for a greater range of medical devices used by both professionals and consumers.

Responses from medical device manufacturers and sponsors noted that a shift towards eIFU will be cost effective for manufacturers, the instructions can be updated easily, additional information like safety concerns, recall, healthcare professional recommendations can be added instantly, and information can be provided in multiple languages.

Responses from medical device consumers, consumer peak bodies, health professionals, hospitals and hospitals peak bodies resonate with overall feedback that the requirements for IFU should move towards eIFU.

Responses noted that eIFU offers significant advantages for consumers and health professionals – it is convenient given almost everyone has access to a phone or computer, and allows flexibility in terms of language, font size, and supports environmental sustainability.

Responses also noted that if changing the requirements, careful consideration of accessibility, security, and regulatory compliance is essential to ensure that eIFU meet the needs of all users while maintaining safety standards.  

There was support for consumers who do not have internet access or are not confident using digital information to be able to access a paper version of the IFU free of charge and within a certain timeframe.

Specific devices that should be provided with an eIFU

There were mixed responses on specific types of medical devices that should be provided with an eIFU. Some suggested that the option for eIFU should be encouraged with all medical devices whereas others suggested that manufacturers should be allowed to determine if an eIFU is appropriate for their product based on factors such as intended users, risk and benefit analysis and probability of device misuse.

There are certain situations where a paper version may be more beneficial over an electronic version including emergency situations (e.g., pacemakers), accessibility issues for vulnerable populations (e.g. elderly), remote or low-resource settings (e.g. war zones), high safety risks, and unreliable technological environments (e.g. inconsistent internet/cellular communication or electricity service). Traditional printed IFUs remain a critical safety component for these scenarios, ensuring users can access information without relying on technology.

Availability of eIFU

Most respondents suggested that the eIFU should be made available until a few years after the expected lifecycle of the product as consumers tend to use a medical device even after the expiry date. There were other suggestions that the duration should be determined based on a number of factors such as type of the device, patient safety, intended user (health professional or consumer), number of updates made, the impact of change to end users, device complexity and manufacturing policies.

Accessibility and storage of eIFU

Most respondents suggested the eIFU to be made available through a manufacturer’s website and consumers be provided with a searchable link or QR code on packaging to access it without having to register or sign-up to their website. There should also be an option to download the eIFU in common and searchable formats like Word or PDF for the purposes of printing.

Most medical device consumers and health professionals stated that they will prefer the TGA website or the Australian UDI database to be the central source for accessing eIFU.

Manufacturers’ requirements for supply of eIFU

Most respondents agreed with the proposed manufacturer’s requirements by the TGA for supply of eIFU with additional suggestions such as multilingual support, accessibility support for disabled users, establishing a process for revision control, notification to all users if information is updated, and removing unnecessary sign-in and password protection to access manufacturer’s website. Those who disagreed had concerns about the need to maintain eIFUs on both the manufacturer’s website and the UDI database.

We have reviewed the feedback received for this consultation. All feedback on the proposals will be provided to the Minister and the Government for their consideration. We will inform stakeholders on the outcomes of the Government’s consideration, including any approval to  progress adopting changes to the requirements for IFUs.

We asked: 

From 22 May 2024 to 23 April 2024, we sought submissions from the public on scheduling proposals referred to the June 2024 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

You said: 

We received a total of 8 submissions in response to the pre-meeting public notice for June 2024. The breakdown of the responses has been provided below: 

SILDENAFIL: A total of 4 votes were received for sildenafil, one in full support, one in partial support and 2 in opposition of the proposal. All submissions provided a written response.

ALLYL ESTERS: No votes were received for allyl esters.

GLYOXYLIC ACID: No votes were received for glyoxylic acid.

INTRAVENOUS POTASSIUM SALTS: A total of 3 votes were received for intravenous potassium salts, all in full support of the proposal. Of these submissions, 2 provided a written response.

SULFONAMIDES: A total of 1 vote was received for sulfonamides, which was in full support the proposal. The submission did not provide a written response.

We did: 

The Delegate considered all submissions prior to making an interim decision on these proposals. The interim decisions on the proposed amendments to the Poisons Standard were published on 19 September 2024. 

The consultation Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated was open from 12 March 2024 to 6 May 2024. This consultation aimed to gather feedback on the appropriateness of current CDSS regulation including exemption criteria, definitions of CDSS, and whether the regulatory requirements were clear. The proposals outlined in the consultation included:

• introducing a definition for CDSS software to provide clarity on the scope of products included and remove any ambiguity
• amendment of the conditional exemption for CDSS software (Schedule 4 Item 2.15 in the Therapeutic Goods (Medical Devices) Regulations 2002) to deliver certainty regarding the application of the exemption and improve transparency for practitioners and professionals by providing oversight of the datasets, information, or evidence underpinning the outputs of the system
• improving guidance for stakeholders with clear interpretations, definitions, and examples to help them understand legislative obligations before and after supply.

Thirty-five responses were received from various stakeholder groups including industry, health professionals, and consumers. Additional targeted discussions were held with representatives from commonwealth, state, and territory government departments.

All proposals received majority support across all stakeholder groups, with some suggested modifications. Feedback from respondents across all stakeholder cohorts confirmed there is confusion about when the exemptions should be applied and health professionals requested greater transparency of how the CDSS outputs can be verified during clinical use.

Key areas of feedback in response to the consultation include:

1. Definition for CDSS software:

The TGA proposed the introduction of a legislative definition for CDSS products to be included in the Regulations to provide clarity on the scope of products included and remove any ambiguity.

Most respondents (60%) across all stakeholder cohorts including members of industry, consumers, and health professionals broadly agreed to introducing a definition to clarify which software systems meet the definition of a CDSS software-based medical device. Respondents who disagreed (40%), including members of the medical device industry, preferred that the definition be included in guidance materials, where more details and case study examples could be provided.

Some respondents suggested minor amendments to the wording of the definition to improve clarity and mitigate concerns.

2. Amendment to the condition of CDSS software exemption in the Regulations:

The TGA proposed that the exemption criteria for certain low-risk CDSS products should be amended to provide clarity regarding the scope of excluded CDSS software functionality. In particular, the TGA wished to clarify the eligibility of software intended for in vitro diagnostic (IVD) and data compression or decompression purposes. Additionally, the TGA intended to clarify the importance of transparency in ensuring health care practitioner oversight of datasets, information, evidence, and review of outputs as key risk mitigation factors for exempt CDSS software. As such, the TGA proposed that exempt software display the details of clinical practice guidelines, calculations, or logic used by the CDSS software to the health professional to enable verification in a manner realistically performed in the intended clinical context.

The majority of all respondents (63%) voted in favour of the proposed amendments. Respondents from across all stakeholder cohorts expressed that certain terms in the exemption criteria need further clarification through guidance including ‘diagnosis’, ‘screening’, ‘triage’, ‘sole purpose’, ‘IVD’, ‘compress’, ‘decompress’, and ‘realistically’. Respondents also requested further clarification regarding the distinction between ‘providing’ and ‘supporting’ clinical decisions.

Respondents requested clarification around the level of technical detail required to be disclosed to the end user in order to meet the exemption criteria, regardless of whether they agreed or disagreed with the proposal.

Responses that indicated disagreement with the proposals stated:

• it would not be feasible to display the level of detail required for clinical validation
• displaying the level of detail required would be difficult to contain within the user interface and would therefore likely negatively impact the usability of CDSS products
• the information would be too technical to be of value to clinicians
• displaying the information could expose proprietary information resulting in the risk of plagiarism or misuse of data.

3. Improvement of guidance, resources, education, and communication:

Sponsors and manufacturers rely on the TGA’s general guidance on exempt CDSS software to provide detailed interpretations and definitions relating to their products. The consultation paper sought feedback on any opportunities to improve guidance materials.

The TGA received feedback that stakeholders believe a general review of the TGA website is required to improve accessibility to existing content and to identify where additional guidance is needed in relation to the exemption and software as a medical device more broadly. These respondents requested that the TGA:

• publish additional diverse examples and case studies
• use plain language, reduce jargon, and provide definitions
• develop and publish flow charts and decision trees
• streamline guidance materials into a central ‘software hub’
• frequently review and update guidance.

In addition, respondents requested specific guidance regarding:

• electronic medical records and clinical information systems
• AI and machine learning
• AI transcribing technology and AI-driven analyses for non-diagnostic purposes
• further guidance on the application of the conditions of exemption for certain low-risk CDSS products under Schedule 4 Item 2.15 of the Regulations.

The TGA will use feedback from this consultation to inform any future proposed amendments to CDSS regulation. Additionally, the TGA will improve and expand existing guidance materials to help stakeholders understand and comply with their regulatory obligations in this area.

From 3 April 2024 to 17 April 2024, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the November 2023 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written submission.

A total of 32 submissions were received through the consultation, 21 from individuals and 11 from organisations. A breakdown of the submissions can be found below.

ASTODRIMER SODIUM: 11 submissions were received, 10 in full support, and 1 in partial support of the interim decision. Of these, 10 provided a written component, 9 written submissions in support, and 1 in partial support.  

BILASTINE: 1 submission was received, which was in full support of the interim decision. No written component was included.

BPC-157: 1 submission was received, which was in full support of the interim decision. No written component was included.

GLYCOPYRRONIUM: 2 submissions were received, which were in opposition of the interim decision. All submissions included a written component.  

METHENAMINE: 4 submissions were received, 1 in full support, 2 in partial support, and 1 in opposition of the interim decision. Of these, 3 provided a written submission, 2 were in partial support and 1 was in opposition of the interim decision.  

NARATRIPTAN: 1 submission was received, which was in full support of the interim decision. No written component was included.  

PARACETAMOL: 6 submissions were received, 2 in full support, 1 in partial support, and 3 in opposition of the interim decision. Of these, 3 provided a written submission, 1 in support, 1 in partial support and 1 in opposition of the interim decision.  

ANIMAL BLOOD PRODUCTS: 1 submission which included a written component was received, the submission was in support of the interim decision.

BILE ACIDS: 1 submission which included a written component was received, the submission was in opposition of the interim decision.

ADRENALINE: 2 submissions were received, which were in full support of the interim decision. No written component was included.

BENZOIC ACID: 2 submissions were received, which were in full support of the interim decision. Of these, 1 submission included a written component.

MELOXICAM: 11 submissions were received, which were all in full support of the interim decision. Of these, 5 provided a written component.

PALMITOYLETHENOLAMIDE (PEA): 2 submissions were received, which were both in support of the interim decision. All submissions included a written component.

CAMPROMORELIN: No submissions were received.

The Delegates considered all submissions prior to making their final decision. The final decisions on the proposed amendments to the Poisons Standard were published on 22 May 2024.

We asked for feedback on two draft guidance web pages we developed to support the changes to TGA oversight of clinical trials of medical devices. The pages describe the review process for first-in-human high-risk implantable or cardiac invasive medical device clinical trials and the expectations for Investigator’s brochures for medical device clinical trials.

We received two submissions, with respondents suggesting some minor points of clarification. 

We thank respondents for providing their feedback, which has been reviewed and incorporated into the draft guidance. The guidance will soon be published on the TGA website.

The supply of medicines can be interrupted for various reasons, causing significant impact on the health and wellbeing of Australians.

At the Therapeutic Goods Administration (TGA), we have improved how medicine shortages and discontinuations are managed in many ways. But we want to do more to further reduce the impact for Australians.

We wanted to hear from people who are impacted by medicine shortages and discontinuations including individual consumers and health professionals, consumer and health professional organisations, the pharmaceutical industry and state and territory health departments.

We asked them:

• How do medicine shortages and discontinuations impact you?
• What challenges and barriers do you face when you’re planning for and responding to medicine shortages and discontinuations?
• How do you ask for, receive and communicate information about the availability of medicines? What are the challenges and barriers you face doing this?
• What do you think the TGA, you, and others could do to improve the situation? How can we collaborate to face the challenges and barriers to a reliable supply of medicines in Australia?

We are using the feedback we received to make recommendations for improvements to further reduce the impact of medicine shortages and discontinuations on Australians.

We received 221 submissions in response to the consultation. These came from:

• state and territory health departments
• health professional representative bodies
• pharmaceutical industry representatives
• consumer representative groups
• individual healthcare professionals
• individual consumers.

These submissions provided a range of experiences and views on medicine shortage impacts, challenges and improvement opportunities.

Stakeholders also raised concerns on the vulnerability of Australia’s medicine supply chain and Australia’s reliance on overseas manufacturing of medicines.

Impacts of medicine shortages and discontinuations

A significant number of respondents from all stakeholder groups outlined the considerable time and resources it took for them to monitor and address medicine shortages and discontinuations.

Although the specific activities involved were different depending on the respondent’s situation, the sustained effort required to manage shortages was reported consistently. Respondents also reported the significant impact of this effort on their health, finances and workloads, whether they were consumers, health professionals or were involved in the industry.

Another reported impact of medicine shortages and discontinuations was the increased strain on the public health system when community-based patients go to hospitals in search of their medicine.

Several respondents also highlighted that medicine shortages and discontinuations disproportionately impact certain population groups, including First Nations people and people living in rural and remote areas of Australia.

Medicine shortages most frequently mentioned 

We asked all respondents to list medicine shortages that have impacted them over the past 12 months. The medicine shortages most frequently mentioned were:

• lisdexamfetamine capsules
• semaglutide injections
• menopause hormone therapy patches
• opioid oral liquid (discontinuations)
• antibiotic medicines
• combination blood pressure and cholesterol-lowering medicines

Opportunities for improvement

Most respondents expressed a desire for improved access to and content of medicine shortages information. They wanted:

• to receive notifications about shortages and discontinuations sooner
• notifications about shortages and discontinuations to be tailored to their interests and needs
• greater transparency about the reasons for a medicine shortage
• consistent and location-specific information about stock availability
• more accurate return-to-supply dates.

There was general support for earlier coordination, engagement and collaboration between the TGA, the pharmaceutical industry and key stakeholders when a medicine shortage is predicted.

Some respondents indicated that current regulatory processes were impacting their capacity to effectively manage or respond to medicine shortages. They wanted prescribing, dispensing and manufacturing regulations to be more flexible and easier to comply with.

Other matters relating to the supply of medicines in Australia

We also received a number of submissions from individual consumers and health professionals advocating for the registration of specific COVID-19 vaccines and treatments. This issue was beyond the scope of the consultation.

The TGA analysed all submissions to the public consultation and compared the feedback with the findings from our recent market research survey, which ran from 23 February 2024 to 13 March 2024.

This market research consisted of an online survey (800 participants) and 17 one-on-one interviews. The participants were individual consumers, pharmacists and prescribers. They were asked about the clinical, economic and lifestyle impacts of medicine shortages and discontinuations. All participants were reimbursed for their time.

Market research - Understanding the impact of medicine shortages in Australia.

Summary of challenges and barriers

We summarised the public consultation and market research feedback about the challenges and barriers of medicine shortages and discontinuations, under 6 themes:

1. Information can be inconsistent, inaccurate, come too late, or be out of date

• When a health professional prescribes a medicine, they often won’t know if it is available or in short supply,  or where to find information about alternatives, especially if a medicine has been discontinued.
• Consumers and pharmacists feel they receive varied and out-of-date information about the availability of medicines during shortages.
• Pharmaceutical companies (sponsors) don't find out about a competitor's product shortage in time to manage the possible increased demand for their product.

2. Sponsors don’t have to report shortages of all important medicines

• The TGA introduced a mandatory reporting scheme for medicine shortages and permanent discontinuations of all prescription and some over-the-counter medicines in 2019. However, the requirement for sponsors to report shortages to the TGA does not cover all medicines that are important to the health of consumers in Australia.
• Non-reportable medicines mentioned in the consultation include:
  • radiopharmaceuticals
  • contrast agents (for medical imaging)
  • intravenous saline
  • paediatric analgesic medicines
  • topical scabies treatments.

3. Low confidence or uncertainty in the supply chain can lead to stockpiling behaviour by consumers and pharmacies.

• When consumers and pharmacists are not confident in the reliability of their medicine supply or do not fully understand the reason for a shortage or discontinuation, they can resort to stockpiling to ensure continuity of supply. This makes it difficult for sponsors to predict demand.
• It’s difficult for sponsors to predict how long and severe a medicine shortage will be when the reason is outside of their control, such as fluctuations caused by competitor shortages, excessive stockpiling and changes to what the medicine is being prescribed for.
• Consumers feel there is limited coordination between their healthcare professionals when responding to medicine shortages. They feel they must take on the responsibility of finding solutions which can lead to delays in accessing their medicines and reduced confidence in the medicine supply chain.

4. Consumers with limited treatment options are disproportionately impacted by medicine shortages and discontinuations

• Consumers experience significant impacts when there are few or no suitable alternatives available for a medicine in shortage or discontinued. For example, we heard from several individual healthcare professionals about the impact of the recent colestyramine powder sachet shortage for people using it as a last line therapy for severe diarrhoea following ileal resection. Many people rationed their remaining supply because there were limited alternative treatments available for this condition.
• Consumers who use medicines for rare conditions face greater impacts when those medicines are discontinued as there are often few alternatives on the Australian market. For example, the recent discontinuation of lomustine capsules sparked significant concern from the Australian oncology community because there are very few alternatives available to treat glioblastoma, a rare and aggressive brain cancer.

5. Time-consuming and manual administrative and regulatory processes for accessing alternative medicines cause delays to treatment.

• Consumers face manual and time-consuming steps when attempting to access an alternative medicine, including travelling to multiple pharmacies and making additional appointments. This disproportionally impacts consumers in rural and remote areas who have further to travel to pharmacies and prescribers.
• Sponsors report that many regulatory and administrative requirements for monitoring, reporting and responding to medicine shortages and discontinuations are manual and time-consuming. This diverts attention from actively managing the medicine shortage.
• Some of the TGA’s regulatory processes and systems are perceived to be inefficient and can hinder timely management and communication of medicine shortages and discontinuations.  For example, the process of adding new overseas medicine approvals to the Section 19A Database on the TGA website may take several days, causing delays in making this information accessible to consumers and healthcare professionals.
• Some hospitals and health organisations are investing significant time and resources developing the same guidance and alerts about how to manage individual medicine shortages and discontinuations. This duplication of effort wastes time and resources that could be used more effectively elsewhere.

6. There are inequalities in the distribution of and access to limited stock*

• Some alternative medicines can be more costly. Consumers on lower incomes have reduced access to medicines during a shortage and it can push some consumers into the public hospital setting.
• Consumers with limited health literacy are more at risk of negative clinical outcomes from delays in accessing medicines.
• Pharmacies that can afford to purchase and store extra stock experience lesser impacts of medicine shortages and potentially limit access to stock for other pharmacies.

*Please note, issues mentioned within challenge theme 6 fall outside the TGA’s regulatory jurisdiction. However, we recognise these challenges have a considerable impact on consumers and health professionals and will be directed to the relevant areas of the Department.

Recommendations for reforms 

Medicine supply chains are complex global systems involving many parties. In June 2024, we hosted a webinar to present the consultation and market research findings to stakeholders in the medicine supply chain including representatives from the pharmaceutical industry, health professional and consumer organisations and state and territory health departments.

These stakeholders also participated in a series of online focus groups to discuss and prioritise issues identified in the consultation and market research, focusing on addressing the most critical and practical issues first.

Outcomes of these discussions, including recommendations on priority areas for potential reform, were provided to the Australian Government for consideration. On 6 November 2024, the TGA announced proposed improvements to TGA’s monitoring and management of medicine shortages and discontinuations.  

We asked for feedback on whether or not certain international scientific guidelines should be adopted by the Therapeutic Goods Administration (TGA).

There were 13 international scientific guidelines being considered in this consultation, as follows:

1. ICH M9 guideline on biopharmaceutics classification system-based biowaivers Step 5
2. Nonclinical safety testing in support of development of paediatric pharmaceuticals S11
3. ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population Step 5 - Addendum
4. ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
5. Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
6. ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.5
7. Guideline on the evaluation of anticancer medicinal products in man
8. ICH guideline E8 (R1) on general considerations for clinical studies Step 5
9. ICH guideline Q3C (R8) on impurities: guideline for residual solvents Step 5
10. ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk Step 5
11. ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes Step 5
12. ICH guideline M10 on bioanalytical method validation and study sample analysis Step5
13. ICH guideline Q3D (R2) on elemental impurities Step 5

While international scientific guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements. Any deviation from a guideline relevant to an application to register or vary the registration of a medicine must be justified.

We received 17 submissions in response to the consultation, including from consumer and industry organisations, government, and from individual consumers.

There was broad support for adopting the 13 guidelines outlined above. Submitted responses, where consent was given to publish, can be found under the ‘Published responses’ section.

Following an extensive process of internal and external consultation to ensure each international scientific guideline is consistent with prevailing requirements in Australia, the TGA has adopted the 13 international scientific guidelines considered in this consultation.

One guideline, the ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.5, required TGA annotation as follows:

• Please refer to the TGA’s webpage TGA Implementation of ICH eCTD v4.0 Specification regarding the TGA’s implementation plan for this guideline.

From 5 January 2024 to 5 February 2024, we sought submissions from the public on scheduling proposals referred to the March 2024 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents could indicate their support or opposition to the proposed amendments with or without a written response.

We received 124 submissions in response to the pre-meeting public notice for March 2024. The breakdown of the responses is provided below:

For cytisine, a total of 41 responses were received, 3 in opposition, 2 in partial support and 36 in full support of the proposed interim decision.

For dextromethorphan, a total of 14 responses were received, 5 in opposition, 2 in partial support and 7 in full support of the proposed interim decision.

For dihydocoodeine, a total of 12 responses were received, 4 in opposition, and 8 in full support of the proposed interim decision.

For ethylmorphine, a total of 10 responses were received, 2 in opposition, 2 in partial support and 6 in full support of the proposed interim decision.

For ethyl lactyl retinoate, a total of 9 responses were received, 2 in opposition, 1 in partial support and 6 in full support of the proposed interim decision.

For niclosamide, a total of 6 responses were received, 1 in partial support and 5 in full support of the proposed interim decision.

For oxytetracycline, a total of 23 responses were received, 19 in opposition, and 4 in full support of the proposed interim decision.

For tranexamic acid, a total of 9 responses were received, 2 in opposition, and 7 in full support of the proposed interim decision.

The Delegate considered all responses prior to making an interim decision on these proposals. The interim decisions on the proposed amendments to the Poisons Standard were published on 26 July 2024.

 

Between 8 December 2023 and 31 January 2024, we undertook a public consultation to seek feedback on the appropriateness of the proposed requirements in the draft quality standards for MDMA and psilocybin.

We received 25 submissions from sponsors, manufacturers, pharmacists, health-care practitioners, industry associations, patients and members of the public.

There was broad in-principle support for the proposed quality standards for MDMA and psilocybin, however a number of suggestions for minor technical changes were recommended:

• Changes to the assay limits for active pharmaceutical ingredients (API) and finish product for both MDMA and psilocybin.
• Changes to the testing limits for impurities, heavy metals, and residual solvents.
• Employing United States Pharmacopeia (USP) or International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines as an alternative to European Pharmacopoeia methods and limits.
• Including additional testing, such as loss on ignition, appearance and content uniformity.
• Including a transition period to allow sufficient time to develop and validate methods for testing the APIs and finished products.

All submissions that gave permission to be published on our website are available through the ‘View submitted responses’ link below.

We appreciate all the feedback and thank all respondents for their submissions.

We have considered all of the submissions, and in response, some minor amendments will be made to the draft standards for MDMA and psilocybin.

A summary of the responses, the rationale for our decisions and the proposed changes are outlined in the Proposed quality standards for MDMA and Psilocybin – Consultation outcomes paper.

The quality standards will be registered as Therapeutic Goods Orders (TGO) on the Federal Register of Legislation in mid-2024 and will have a commencement date of 6 January 2025 to allow industry time to develop and validate test methods.