We asked, You said, We did

We asked for feedback on a streamlined approach with commensurate reduced fees for UDI Consent to Supply.

We received 23 submissions. Most were from sponsors, with 2 from industry bodies and a small number of manufacturers.

All respondents supported the introduction of a streamlined approach for UDI only consent to supply. Most supported one of the reduced fee options, though some requested no fee or bundling the fee into annual charges.

Respondents asked that the TGA provide clear instructions on how to complete a UDI Consent to Supply application. They noted this would support submission of high-quality applications and reduce administrative burden for both industry and the TGA.

Based on the consultation outcomes, we will seek Government agreement to refine the Regulations. The proposed refinements would:

• reduce the fees associated with UDI Consent to Supply applications
• include a refund provision for sponsors who paid the full Consent to Supply fees before Regulation changes take effect.

We will update supporting documents and UDI Guidance following a decision from the Government on the proposed refinements and to address requests raised in the consultation.

From 19 December 2025 to 12 January 2026, we sought submissions from the public on the Delegate’s interim decisions on adrenaline previously discussed at the June 2025 meetings of the Advisory Committees on Medicines 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 4 submissions were received through the consultation, all from organisations. Of the submissions, 3 were in full support, and 1 was in partially support of the interim decision. All submission included written justifications.

The Delegate considered all submissions prior to making the final decision. The final decision on the proposed amendment to the Poisons Standard was published on 22 January 2026.

We invited feedback on proposed amendments to regulate medicinal maggots. The proposal included the following key elements:

• introducing a time-limited GMP exemption for current domestic manufacturers of medicinal maggots
• classifying medicinal maggots as Class 2 biologicals

Specifically, we sought feedback on whether:

• a 2-year transitional GMP exemption would provide sufficient time for the sector to achieve GMP compliance
• the proposed scope of people covered by the exemption was appropriate and adequate
• classification as a Class 2 biological was appropriate, including whether the legislation should define the intended clinical use and scope of medicinal maggots
• applying Therapeutic Goods Orders (TGO) 107 and 109, with appropriate adaptations, would be adequate

We received submissions from registered healthcare professionals, academics, industry representatives, regulatory professionals, and members of the public. Key themes from the feedback included the following:

• Transitional GMP exemption: The majority of respondents supported a two-year transitional exemption from GMP requirements. They emphasised that this exemption would help ensure continuity of supply and support the economic sustainability of medicinal maggots production. Respondents considered the proposed timeframe practical, as it would minimise disruption to patient care while giving the sector adequate time to achieve GMP compliance.

• Class 2 biological classification: Respondents strongly supported explicitly classifying medicinal maggots as Class 2 biologicals. Stakeholders noted that this approach aligns with international regulatory practices and reflects the established safety profile of these products. They also highlighted that clear classification would provide regulatory certainty, simplify compliance requirements, and support access to maggot therapy for wound care across Australia. While a small number of submissions raised concerns about potential cost impacts associated with GMP requirements, respondents generally accepted these requirements as necessary to protect patient safety.

• Intended clinical use: Stakeholders strongly supported allowing clinicians to use their professional judgement to determine the intended use of maggot therapy, rather than limiting its use solely to debridement. Respondents noted that medicinal maggots provide multiple therapeutic benefits, including reducing bioburden, exerting antimicrobial effects, and stimulating granulation tissue. Many considered restrictive definitions impractical and likely to unnecessarily limit patient care.

• Definitions and contraindications: The majority of stakeholders supported a broad and flexible definition of medicinal maggots, without prescriptive lists of indications or contraindications. Respondents  emphasised that clinical guidelines and product labelling are more appropriate mechanisms for guiding practice. They cautioned that rigid regulatory exclusions could quickly become outdated and restrict appropriate clinical use.

• TGO 107 and TGO 108: Respondents broadly supported applying TGO 107 and TGO 109 to medicinal maggots, provided the requirements are adapted to account for their characteristics as living organisms. Stakeholders noted that requirements for absolute sterility and donor-related provisions are not appropriate in this context. Many recommended developing tailored guidance to support safety while avoiding unnecessary regulatory burden.

After considering all submissions, we intend to proceed with the proposed legislative amendments for medicinal maggots. In particular, we will:

• amend the legislation to introduce a transitional 2-year GMP exemption for medicinal maggots
• classify medicinal maggots as Class 2 biologicals
• work with industry representatives to develop guidance and education resources to support a smooth and effective transition
• publish individual submissions in line with respondent consent. 

For further questions, contact TGA.scientific@health.gov.au.

We asked for feedback on a proposal to introduce an interim provision for current domestic manufacturers of bacteriophage therapy products (BTPs) by the introduction of a time-limited GMP exemption.

Specifically, we sought feedback on whether:

• the exemption should be limited to manufacturers of personalised or small batch BTPs only
• the details of the people to be covered by the exemption are appropriate and adequate
• a 2-year limit will provide enough time for the sector to achieve GMP and allow TGA to further consider an appropriate level of regulatory oversight of bacteriophage in Australia.

We received submissions from registered health professionals, academics, industry, and BTP manufacturers.

A majority of respondents requested that the exemption be for more than 2 years to allow the sector enough time to achieve GMP status.

We received strong feedback that the exemption needs to cover a multidisciplinary team, not just medical practitioners, due to the complex and multifaceted manufacturing process.

After reviewing all the submissions, we now intend to amend the legislation to allow a time-limited (3 year) GMP exemption for small batch bacteriophage therapy products.

We will continue to support the sector during the transitional period through education and consideration of the need for the development of industry standards, with the aim of facilities achieving GMP status at the end of the exemption.

Full regulatory requirements will still apply to higher risk, large-scale manufacturers of bacteriophage, as they will not be exempt from GMP licencing.

For further questions, contact TGA.Scientific@health.gov.au.

We invited feedback on proposed amendments to strengthen the legislative framework for Technical Master Files (TMFs) for blood and blood components, and Plasma Master Files (PMFs) for Type II plasma-derived products. The key elements of the proposal included:

• Move the exemption from Schedule 5 to Schedule 5A of the Regulations and add specific conditions to regularise existing processes.
• Consequential changes that include partial redrafting of the Therapeutic Goods (Manufacturing Principles) Determination 2020 to remove current TMF and Type II PMF references to align with the new regulatory framework.
• Insert a new prescribed fee into Schedule 9 of the Regulations.

We received submissions from manufacturers and industry organisations.

There was overall support for the proposed amendments to strengthen the legislative framework for TMFs for blood and blood components, and PMFs for Type II plasma-derived products.

Key considerations

• All respondents endorsed the proposals to strengthen the legislative framework and regularise existing requirements to submit annual TMF and Type II PMF updates and to collect the associated evaluation fee, citing it as a positive development.
• All respondents expect minimal operational impact, citing that the evaluation process and fee structure will largely remain unchanged, and that the proposed amendments reflect current routine practice.
• Broad support emerged for the consequential changes to the Manufacturing Principles (the Determination), recognising these updates will align the Determination with the new regulatory framework. However, several respondents requested further clarification on whether these updates would impact current GMP licensing status and recommended that the TGA define and confirm that existing GMP licences will not be affected, to provide certainty for manufacturers.
• Stakeholders recommended that the TGA update its website and related guidance materials to facilitate implementation, industry understanding and compliance.

We now intend to amend the legislation to strengthen the regulatory framework for TMFs and Type II PMFs as proposed in the consultation. In particular, we will:

• Amend the legislation to regularise TMF and Type II PMF evaluation processes and fees.
• Work with industry representatives to develop comprehensive guidance to support a smooth and effective transition.
• Publish individual submissions in line with respondent consent from the consultation.

For further questions, please contact TGA.scientific@health.gov.au.

We asked for feedback on proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month transition period to ensure consistency with Australian legislative requirements for clinical trials involving unapproved medicines and biologicals under the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes.

We received 51 submissions in response to the consultation. Respondents provided a range of suggestions to improve the annotations and topics for guidance, with most supporting the 12-month transition period. We appreciate all the feedback received.

We considered all feedback received and made changes to the annotations. We have adopted ICH E6(R3): Principles and Annex I, which will take effect on 13 January 2026 and mark the start of a 12-month transition period. For more information see ICH Guideline for Good Clinical Practice.  

Changes we made in consideration of feedback included:

• Updating the introduction to make it clearer that TGA comments are prepared to assist stakeholders in complying with ICH E6(R3) in accordance with local regulatory requirements.
• Including a link to the other guidelines adopted by the TGA to assist stakeholders in complying with ICH E6(R3).
• Citing specific chapters and paragraphs in the National Statement that address special cases of informed consent, including guidance on obtaining valid consent where individuals lack capacity and on alternative pathways for recruiting participants
• Specifying the period for which records should be retained is determined by applicable state, territory and/or national law, together with prevailing standards for the specific type of research.
• Clarifying that permanent retention periods may apply for certain trial types.
• Providing details to support the National Statement requirements for trial registration and the timely dissemination of trial results.
• Minor changes including clarification of ambiguous phrasing and grammar, punctuation and/or formatting.

We appreciate your suggestions for future guidance topics. They have been noted and will help inform the focus of our educational resources.

We asked for information on stakeholders’ experiences, observations and knowledge of the use of unapproved medicinal cannabis products, including medicinal cannabis medicines and medicinal cannabis devices.

Specifically, we sought feedback on:

• Whether there is appropriate regulatory oversight of unapproved medicinal cannabis products being accessed via the unapproved pathways, the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme and
• If there are safety risks associated with unapproved medicinal cannabis products, particularly those products containing delta-9-tetrahydrocannabinol (THC), noting the rapid growth in the number of Australian patients that have been prescribed these products since 2017.

Participation

We received 790 submissions from the following stakeholder groups:

• Academics
• Advocacy/special interest groups
• Consumers and patients
• Carers and people with a special interest
• Industry/sponsors
• Peak body organisations
• State and territory, and other Commonwealth Departments
• Healthcare professionals (e.g. medical practitioners, pharmacists, nurse practitioners etc)
• Medical colleges

Overall stakeholder support

There was agreement across stakeholder groups that the current access framework, used for exceptional clinical circumstances, is not fit-for-purpose and not proportionate to the potential safety and quality risks associated with unapproved medicinal cannabis products. While reform was generally supported, there was a strong desire to carefully consider any impact to patient access.

Key considerations

• There is limited consumer/patient knowledge of the unapproved status of medicinal cannabis, and that these products have not been evaluated by the TGA for safety, quality, efficacy or performance.   
• Safety concerns were raised around products with high amounts of THC being accessed under the unapproved pathways. While it was not possible to determine a ‘safe’ upper limit for THC from the consultation, submissions did note that high potency THC products can increase risks of harm, such as acute psychosis and cannabis use disorder.
• Safety risks across all dosage forms were identified, with the most prominent concern relating to dried herb (smoking/vaping) and concentrated extracts (vaping). The availability of confectionary-like formulations, such as pastilles and gummies, was also raised as a concern in many submissions, noting the potential risks of accidental ingestion, particularly by children.
• Many submissions support greater enforcement of product quality standards, with consistent application and enforcement measures in place for both domestic and imported medicinal cannabis products. There were also strong calls for the establishment of device quality standards for medicinal cannabis.
• All stakeholder groups would like strengthened packaging and labelling requirements, with calls for restrictions to inappropriate product trade names, the introduction of plain packaging, standardisation of THC/CBD expression, mandatory warning statements, transparency of registration status, Product Information documents and child-resistant closures.
• Most stakeholders consider cannabidiol (CBD), a prescription medicine in Australia, to be well tolerated by patients. Some submissions highlighted the potential for contraindications and interactions. While CBD was viewed as having a more favourable safety profile compared to THC, stakeholders also emphasised the limited availability of high-quality safety and efficacy data.
• There is strong support for restricting access to THC-containing products in certain high-risk populations, to minimise the potential for adverse clinical outcomes.

It was evident from submissions that many consumers/patients are not aware of the nature and implications of the unapproved status of the majority of medicinal cannabis products prescribed. As such, the TGA is undertaking actions to support health care practitioners and consumers to better understand the risks associated with unapproved medicinal cannabis products. In doing this, we will also aim to explore collaborative clinical education opportunities with other health regulators, reminding prescribers of their responsibilities and conditions of their approvals when prescribing unapproved medicinal cannabis products.

The TGA will continue to engage with stakeholders as part of a broad collaborative approach to strengthen the medicinal cannabis framework in order to better safeguard the Australian community.

For further questions, contact medicinalcannabisreforms@health.gov.au

We invited feedback on proposed changes to the classification rules and definitions for in vitro diagnostic (IVD) medical devices in Australia. The key elements of the proposal included:

• Aligning Australian IVD classification rules, principles and definitions with the European Union’s IVD Regulation (EU IVDR 2017/746) where appropriate.
• Reclassifying certain IVDs (e.g. cancer tests, newborn screening, control materials and subsets of software and instruments) to ensure scrutiny is proportionate to the risk posed by their intended purpose and use.
• Adopting clearer terminology and definitions to improve consistency and interpretation.

Participation: We received 25 submissions from a broad range of stakeholders including industry, laboratories, public pathology and community health organisations.

Overall support: There was overall support for international alignment and clearer, risk‑based classification, particularly for cancer‑related tests, preliminary testing and monitoring devices, and newborn screening tests. Stakeholders said this would reduce ambiguity and improve consistency across Australian Register of Therapeutic Goods (ARTG) entries.

Key considerations

• Respondents said that international alignment offers clear benefits, including reduced duplication and lower regulatory burden to access the Australian market.
• Some respondents said the TGA should treat already established instruments pragmatically with minimum regulatory burden, and any re-validation costs for small volume tests should also be minimised to reduce supply disruptions of those tests. 
• There was overall broad support for aligning the classification of assigned‑value controls with that of the associated assay. However, concerns were raised that any change should not include all qualitative controls and only include those controls that are used to validate the test result. Stakeholders asked the TGA to tighten the terminology and clarify its applicability in the guidance to avoid unintended consequences.  
• Respondents acknowledged that software should be classified based on its intended purpose but asked the TGA to develop clearer guidance, similar to internationally available guidance, to explain how intended purpose determines risk classification, supported by practical examples.
• Respondents asked us to align with the EU interpretation and published definition of ‘life-threatening condition’.
• There was strong feedback to retain Point‑of‑Care Testing (PoCT) terminology while incorporating the “near‑patient testing” concept, to avoid label divergence. Respondents also said that the change must not exclude trained healthcare workers given the demonstrated public‑health benefits in remote and priority settings.
• Some stakeholders supported a staggered transition period that ended 6 months after each of the respective staggered EU IVD Regulation transition timelines. However, others suggested a 12–24-month transition, to allow them time to update product portfolios and Quality Management System documentation.

Suggestions to support implementation

• Publish practical guidance and worked examples (especially for software, artificial intelligence, instruments and control materials); and
• Continue to align with international guidance, e.g. guidance under the European IVD Regulatory framework to minimise regulatory discrepancies.

We consolidated the consultation feedback on the proposed changes to the IVD classification and definitions and did further targeted consultation to understand concerns raised about the potential impact of the proposed changes. We published individual submissions in line with respondent consent for publication.

Next steps

• We will hold workshops with industry representatives to discuss transition arrangements (including the transition timelines) to minimise any potential impact on market availability.
• We will seek Government approval for the final proposal, informed by consultation feedback.
• Subject to approval by the Government, we will collaborate with industry representatives to develop clearer guidance, including practical examples, to support a smooth and effective transition.

From 14 March 2025 to 4 April 2025, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at 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 submission.

A total of 12 submissions were received through the consultation, 4 from individuals and 8 from organisations. A breakdown of the submissions can be found below.

ASTODRIMER SODIUM: 5 submissions were received, 2 in full support, and 3 were in opposition of the interim decision. All those in opposition provided written components.

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

ETHYLENE OXIDE, PROPYLENE OXIDE, EPICHLOROHYDRINE: 7 submissions were received, 1 in full support and 6 in opposition of the interim decision. All the 6 in opposition provided written components.

SYMPHYTUM OFFICINALIS (COMFREY): 7 submissions were received, 3 in full support and 4 were in opposition of the interim decision. Of these, 1 in support and all 4 in opposition provided written components.

The Delegate considered all submissions prior to making the final decisions. The final decisions on the proposed amendments to the Poisons Standard were published on 19 May 2025.

From 14 February 2025 to 18 March 2025, we sought submissions from the public on the delegate’s interim decision relating to intravenous potassium salts. 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 17 submissions were received through the consultation for intravenous potassium salts, 9 in full support, 6 in partial support, and 2 in opposition of the proposal. Of the 17 submissions, 12 provided written responses – 4 in support, 6 in partial support and 2 in opposition.

The Delegates considered all submissions prior to making their final decision. The final decision on the proposed amendments to the Poisons Standard was published on 19 January 2026.

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

There were 19 international scientific guidelines being considered in this consultation, as follows:

1. Annex 1 WHO guidelines on nonclinical evaluation of vaccines
2. Annex 2 – Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines
3. Bioequivalence for immediate-release solid oral dosage forms – M13A
4. Quality Working Party questions and answers on API mix
5. Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)
6. Guideline on good pharmacovigilance practices (GVP) Module VIII – Post authorisation safety studies (Rev 3)
7. Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract
8. Guideline on the clinical evaluation of anticancer medicinal products
9. Guideline on the assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products
10. Guideline on control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “substances for pharmaceutical use” and general chapter “control of impurities in substances for pharmaceutical use”
11. Appendices to Guideline on epidemiological data on blood transmissible infections
12. Guideline on epidemiological data on blood transmissible infections
13. Guideline on the chemistry of active substances
14. Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry
15. Aliskiren film-coated tablet 150mg and 300mg product specific bioequivalence guidance
16. Apixaban film-coated tablet 2.5 and 5mg product -specific bioequivalence guidance
17. Drug Interaction Studies M12
18. Nonclinical Biodistribution Considerations for Gene Therapy Products S12
19. ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

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

There was broad support for adopting the 19 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 19 international scientific guidelines considered in this consultation.

Three guidelines required TGA annotation as follows:

1. Quality Working Party questions and answers on API mix, required TGA annotation as follows:

EMA filing procedures and CEP requirements are not applicable to submissions made to the TGA.

2.  Guideline on the assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products, required TGA annotation as follows:

Applicants must be able to demonstrate an established tradition of use for traditional use indications in Australia. Please refer to the Overview of the regulation of listed medicines and registered complementary medicines, which identify traditional use as generally equating to three generations of human use.

3.  ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, required TGA annotation as follows:

The following change is to be applied to the guideline: Table 4 Case B – Test for virus in purified bulk – yesj; j. The absence of detectible virus should be confirmed for purified bulk by means of suitable methods having high specificity and sensitivity for the detection of the virus in question. For the purpose of marketing authorisation, data from at least 3 lots of purified bulk manufactured at pilot-plant or commercial scale should be provided. However, for cell lines such as CHO cells for which the endogenous particles have been extensively characterised and adequate clearance has been demonstrated, it is not usually necessary to assay for the presence of the non-infectious particles in purified bulk. Note: For marketing authorisation, typically RVLP quantification data from 3 lots or more of purified bulk at pilot plant scale or commercial scale should be provided.

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.

Update March 2025

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.

Update November 2025

The TGA has reviewed and considered all feedback received about changes to the legislative framework for medicine shortages and discontinuations.

Please note, amendments to the Therapeutic Goods Act 1989 are subject to Australian Government consideration. We will continue to update the TGA website with information about these proposals.

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.  We have delivered our report to the Australian Government.

A copy of our report has been published – Report: Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI)

The Department of Health, Disability and Ageing has published the final report from their overarching review of the use of AI in health and care settings – Safe and Responsible Artificial Intelligence in Health Care – Legislation and Regulation Review: Final Report.

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.

The TGA sought feedback on the drafted revision of the guidance document TGA Instructions for Disinfectant Testing. The consultation principally sought feedback on:

• relevance of the document content
• clarity and consistency of the document content
• technical currency of the document content
• structure of the document
• additional content that would benefit the document user.

7 submissions were received, primarily representing disinfectant product sponsors and manufacturers, and industry bodies.

Respondents provided wide-ranging comments and suggestions across all questions. Overall, the responses supported revision of the TGA Instructions for Disinfectant Testing, and also provided many valuable comments and suggestions for improving the usability and content of the document.

We have analysed all responses, and the results have informed further amendments to the guidance document. The TGA will  publish the new document version on the TGA website in the near future.

Due to the significant changes made to the document, the TGA will organise information sessions with key industry stakeholders. The TGA also recognises that the guidance document would benefit from more frequent review, and will seek to ensure that this occurs.

To maintain alignment between the guidance and regulatory requirements, minor amendments are also required to the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019.  The amended TGO will be registered on the Federal Register of Legislation (FRL) once signed.

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 for boundary 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.

Outcome update - March 2025

The Government has approved the preparation of regulatory amendments that will clearly specify the therapeutic good categories as outlined in the consultation paper for head and body lice products for humans, moisturisers and emollients, toothpastes, products generated by ozone generators, and weight loss treatment for ingestion. We are working on drafting the required changes and updates to the Understanding rules for boundary and combination products guidance. We expect the changes to be implemented later in 2025.

We have considered all feedback received in relation to the regulation of pre-filled saline flush syringes and vascular access device locking solutions, and are finalising our submission, including stakeholder feedback to the Government. Pending the outcome of the Government’s decision, we will inform stakeholders of the next steps.

Outcome update – August 2025

The Government has now approved the following in relation to Vascular Access Device (VAD) locking solutions and Pre-filled saline flush syringes (PFSFS):

• The regulatory category of saline depends on the primary intended purpose of the product.
• If the primary intended purpose of saline is for flushing, irrigating, or maintaining the patency of a medical device, then the saline is not considered a medicine in these products and these products are regulated as medical devices.
• VAD locking solutions and PFSFS without ancillary medicinal substances such as antihistamines/anti-coagulants/antibiotics be regulated as Class IIa medical devices in Australia.
• VAD locking solutions and PFSFS with ancillary medicinal substances such as antihistamines/anti-coagulants/antibiotics are regulated as Class III medical devices in Australia.
• Legislative refinements will be made to support the above classification rules for VAD locking solutions and PFSFS.
• Guidance documents will be updated to support education and communication of the proposed changes.
• Transition arrangements of up to 5 years will be available for any affected entries.

Guidance will be updated to support these changes, with changes expected to take effect in late 2025. Relevant stakeholders such as sponsors and health professionals will be notified when we have a date for the changes to come into effect.

Important note: At this stage, we will not proceed with exempting head and body lice products for human use, moisturisers and emollients, toothpastes, products generated by ozone generators, weight loss treatments intended for ingestion, where they meet the definition of a medical device, as was proposed in the consultation paper. These exemptions will instead be considered as part of the Exempt Devices and OTG project. We are still proceeding with clarifying their legislative categories as per the consultation paper (ie medical device, biologic or medicine) but we will not proceed with exempting any medical device product types at this time.