We asked, You said, We did

Between 5 October 2023 to 2 November 2023, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the June 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 response.

A total of 9 submissions were received through the consultation, 1 from an individual and 8 from organisations. A breakdown of the submissions can be found below.

Bisacodyl: 2 submissions were received for bisacodyl, both supportive of the interim decision. Both submissions contained a written component in support.

Olopatadine: 2 submissions were received, both partially supportive of the interim decision. Both submissions included a written component.

Ibotenic acid: 3 submissions were received, with 1 in support of the interim decision and 2 in partial support. All submissions included a written component.

The Delegates considered all submissions prior to making their final decision. The final decisions on the proposed amendments to the Poisons Standard (except for amygdalin and hydrocyanic acid) were published on 15 December 2023.

From 1 September 2023 to 29 November 2023, we sought submissions from the public on scheduling proposals referred to 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 response. 

We received 237 submissions in response to the pre-meeting public notice for November 2023. The breakdown of the responses is provided below:  

ASTODRIMER SODIUM: 167 responses were received for ASTODRIMER SODIUM 166 in full support, and 1 in partial support of the proposal. Of these, 137 provided a written response, 136 written responses in support, and 1 written response in partial support.  

BILASTINE: 25 responses were received, 24 in full support, and 1 in partial support of the proposal. Of these, 5 provided a written response, all were in support of the proposal.  

BPC-157: 22 responses were received, 21 in full support, and 1 in partial support of the proposal. Of these, 4 provided a written response, all were in support of the proposal.  

GLYCOPYRRONIUM: 28 responses were received, 26 in full support, 1 in partial support and 1 in opposition of the proposal. Of these, 7 provided a written response, 5 written responses in support, 1 written response in partial support and 1 in opposition.  

METHENAMINE: 25 responses were received, 24 in full support, and 1 in partial support of the proposal. Of these, 5 provided a written response, all were in support of the proposal.  

NARATRIPTAN: 26 responses were received, 24 in full support, and 2 in partial support of the proposal. Of these, 4 provided a written response, 3 written responses in support, and 1 written response in partial support.  

PARACETAMOL: 45 responses were received, 34 in full support, and 11 in opposition of the proposal. Of these, 16 provided a written response, 8 written responses in support, and 8 in opposition.  

ANIMAL BLOOD PRODUCTS: 20 responses were received, 18 in full support, 1 in partial support and 1 in opposition of the proposal. Of these, 6 provided a written response, 5 written responses in support, and 1 written response in partial support.  

BILE ACIDS: 17 responses were received, 16 in full support, and 1 in opposition of the proposal. Of these, 2 provided a written response, all were in support of the proposal.  

ADRENALINE: A total of 23 responses were received, 22 in full support, and 1 in opposition of the proposal. Of these, 5 provided a written response, all were in support of the proposal.  

BENZOIC ACID: 21 responses were received, 18 in full support, and 3 in opposition of the proposal. Of these, 5 provided a written response, 2 written responses in support, and 3 in opposition.  

MELOXICAM: 82 responses were received, 79 in full support, 1 in partial support and 2 in opposition of the proposal. Of these, 60 provided a written response, 57 written responses in support, 1 written response in partial support and 2 in opposition.  

PALMITOYLETHENOLAMIDE (PEA): A total of 19 responses were received, 17 in full support, 1 in partial support and 1 in opposition of the proposal. Of these, 3 provided a written response, 1 written response in support, 1 written response in partial support and 1 in opposition.  

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 3 APRIL 2024

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. Curcuma species and curcumin and the risk of liver injury
2. Green tea extract and the risk of liver injury
3. Safe levels of benzophenone
4. Clarification of the requirements for soy phosphatidylserine-enriched ingredients
5. Clarification of the requirements for Terminalia ferdinandiana

A total of 27 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:

• 10 responses to the proposed liver warning statement for Curcuma species and curcumin
• 7 responses to the proposed liver injury warning statement for Camellia sinensis
• 16 responses to the proposed safety limit on benzophenone
• 4 responses to the proposed update to the requirements for soy-phosphatidylserine enriched ingredients
• 3 responses to the proposed update to the requirements for Terminalia ferdinandiana

The responses varied in stance and recommendations, however, the majority of respondents from the complementary medicines industry did not support or 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 2024. A 12-month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2025.

We invited feedback on a proposed risk-based application audit framework for medical devices, including In Vitro Diagnostic (IVD) medical devices. The framework described how we proposed to select medical device applications for audit and conduct those audits.

The key elements of the proposed application audit framework included:

• risk factors informing non-mandatory audit selection,
• criteria for mandatory audits,
• the evidence to be provided with applications to inform audit selection,
• limiting the number of substantial assessment rounds,
• mechanisms to improve visibility of application audit timeframes
• cost recovery measures for non-mandatory audits, and
• pathways for Class III devices with Medical Device Single Audit Program (MDSAP) certification and US FDA 510(k) approval.

We received twenty-six (26) submissions.

The overall level for the proposed new risk-based application audit framework was positive with broad support for:

• limiting mandatory audits to Class III, Class 4 IVD, Class 3 IVD, point-of-care and self-test IVD medical devices
• exempting medical devices with recognised comparable overseas regulator approvals from mandatory audit
• establishing a new mandatory audit pathway for Class III medical devices with MDSAP and US FDA 510 (k) approval
• repealing clause 5.3(1)(j)(viii) in the Regulations, relevant to IVD medical devices, because it is ambiguous and non-transparent in its operation.

Most respondents supported the proposal for the TGA to publish risk factors that influence non-mandatory audit selection, but they wanted more clarity about the rationale for the proposed risk factors and how each risk factor would be weighted and combined to influence the audit selection decision.

Most respondents expressed concerns about:

• requiring applicants to submit the Instructions for Use and the Clinical Evaluation Report for Class III devices with European Medical Device Regulation certification
• limiting audits to two substantial rounds of review.

Most respondents suggested improvements to the application audit process, including improved communication, transparency, and timeframes. Respondents said we should not delay improvements while we deliver the TGA digital transformation project.

The consultation responses supported the proposed changes to the criteria for mandatory audits and the proposed MDSAP and US FDA 510(k) pathway. The TGA is seeking Government approval to amend the legislation accordingly.

Next Steps

The TGA is also using the feedback from the consultation to:

• develop detailed guidance on the risk factors we will consider when selecting applications for audit. Once the guidance is published, we will review the risk factors periodically
• do further work to review the evidence we require to be provided with applications to inform audit selection. We will review the requirement for applicants to provide clinical evidence for all class III medical device applications with comparable overseas regulator approval
• improve the way we communicate with applicants about these audits
• improve assessment timeframes for these audits, including considering establishing target timeframes.

Between 13 July 2023 to 10 August 2023, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the March 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 response.

A total of 6 submissions were received through the consultation, 1 from an individual and 5 from organisations. A breakdown of the submissions can be found below.

Celecoxib: 2 submissions were received for celecoxib, both supportive of the interim decision. Both submissions contained a written component in support.

Azelaic acid: 4 submissions were received, all in support of the interim decision. All 4 of the submissions provided a written component in support of the interim decision.

Bromoxynil: 1 submission was received in support of the interim decision which contained a written component.

Dioxane: 3 submissions were received, 2 in support and 1 in partial support of the interim decision.  All 3 responses contained a written component, 2 in support and 1 in partial support.

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 4 September 2023.

We asked for feedback on potential changes to the regulatory requirements for non-IVD medical devices that contain tissues, cells, or substances of animal, microbial or recombinant origin.

We sought feedback on:

1. the risk of certain materials of animal, microbial or recombinant origin
2. removing microbial or recombinant tissues, cells, or other substances from classification rule 5.5, Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
3. accepting evidence from a broader range of comparable overseas regulators for devices that contain substances of animal, microbial or recombinant origin.

We received twenty responses.

Most respondents agreed with excluding certain low-risk animal origin materials from classification rule 5.5 and removing “microbial or recombinant origin substances” in general. They commented that these substances are low risk, and the change would align more closely with international regulatory frameworks. Some respondents pointed out that the Essential Principles of the Regulations already specify the safety requirements for the control of animal, microbial or recombinant origin substances.

There was strong support for accepting conformity assessment evidence from a broader range of comparable overseas regulators. Respondents reported that the current requirements are burdensome and have delayed supply of some devices to Australia despite having approvals from recognized comparable overseas regulators. All respondents stated these changes would reduce regulatory burden and enable Australians to have faster access to safe products.

Several respondents asked that the specific labelling requirement related to microbial or recombinant origin substances also be removed from the Regulations to reduce the burden of maintaining Australian-specific Instructions for Use.

The TGA appreciates all the feedback and thanks all respondents.

We analysed the responses and have considered the feedback to shape regulatory reform and policy that is risk-based and that removes unnecessary regulatory burden.

In December 2023, the Government agreed to

a) remove “microbial or recombinant origin substances” from classification rule 5.5 (clause 5.5, Part 5, Schedule 2 of the Regulations)

b) remove associated labelling requirements under Essential Principle 13.4

c) exclude other certain low-risk animal origin materials from classification rule 5.5

d) provide a two-year transition for existing approved devices

e) accept a broader range of comparable overseas regulators for these devices.

We are preparing regulatory amendments for Government approval for possible commencement in mid-2024.

In April - May 2023, the TGA undertook a public consultation on potential clarification and updates to the regulation of sunscreens.

The proposed regulatory clarification and updates included:

1. Adoption of the Australian/New Zealand Standard Sunscreen products – Evaluation and classification AS/NZS 2604:2021 Amd 1:2022 (the 2021 Sunscreen Standard) which specifies the current testing and labelling requirements for sunscreens.
2. Removal of the category of ‘exempt’ sunscreens and previous transitional arrangements from the Therapeutic Goods Regulations 1990 (the Regulations) which enables sunscreen products with less than SPF4 (that were supplied in the market prior to 9 November 2012) to comply with the superseded Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:1998 (the 1998 Sunscreen Standard) and be exempt from the requirement to be included in the ARTG.
3. Clarification on the indications (therapeutic uses) that sunscreens can make.

A total of 19 submissions were received from the therapeutic goods industry (sponsors, manufacturer, industry organisations and regulatory agents), government organisations, non-profit organisations, healthcare professional groups, consumer groups and individuals.

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

The TGA would like to thank those who responded to the consultation.

The feedback we received for each proposal is summarised below.

1. Adoption of the 2021 Sunscreen Standard

The majority of stakeholders supported the adoption of the 2021 Sunscreen Standard as this ensures alignment with international sunscreen testing methodology. A few key points were raised in the consultation response:

• Aerosol/spray pump pack sunscreens: A number of respondents, representing health professionals and consumers, expressed concerns that the introduction of additional labelling instructions for the application of aerosol and spray pump pack sunscreens (as per the 2021 Sunscreen Standard) will not be sufficient to address the risk of sunburn and inhalation for consumers using these products. One respondent considered that aerosol sunscreens should be removed from the market altogether.
• Transition period for compliance with new testing requirements: While the majority of respondents agreed that all new sunscreens should be required to comply with the 2021 Sunscreen Standard from the adoption commencement date, there were concerns raised by industry with the 3-year transition timeframe proposed in the consultation for sunscreens already in the market. The concerns related to testing and supply pressure and the potential shortage of sunscreens in the peak sunscreen use season, as well as concerns with overseas stock production due to ongoing political issues in the European Union. Industry respondents highlighted that the updated standard includes the adoption of new technical testing methodologies, rather than addressing any safety or quality concerns with the previous standard. Given this, they indicated that risk to consumers should be considered low and thus support a longer transition period.
• Transition period for new labelling requirements for aerosol/spray pump pack sunscreens: While there was broad support for a shorter transition time for new labelling requirements for aerosol and spray pump pack sunscreens, some respondents expressed concern that the timing of the commencement and end of the proposed transition period (9 January 2023 and January 2024, respectively) occurs in the peak of sunscreen use season and requested the transition period be extended to avoid the peak summer season.

2. Removal of the outdated exemption for sunscreens with less than SPF4

All respondents were supportive of this proposal and removal of exemption provisions for sunscreens less than SPF4, with no industry stakeholder stating that this would represent a regulatory burden to them.

3. Clarification on sunscreen indications

Respondents were presented with three possible options to consider for clarifying the use of indications for sunscreens:

• Option 1: clarify that listed sunscreens can only use indications permitted for sunscreens (status quo).
• Option 2: allow listed sunscreens to use any permitted indications relating to dermal application.
• Option 3: allow listed sunscreens to use additional specified permitted indications relating to dermal application.

The majority of respondents (67%) from a variety of stakeholders supported maintaining the status quo (Option 1), stating that Australia has an excellent system in place for regulating sunscreens which should be maintained. A number of respondents emphasised the critical importance of primary prevention efforts to reduce the incidence of skin cancer, adding that permitting other indications for sunscreens is likely to lead to confusion for consumers. It was also raised that additional ingredients for other indications may interact with sunscreen ingredients, decreasing efficacy and increasing toxicity, skin absorption and allergenicity.

Some industry respondents supported maintaining the status quo, but request clarification in TGA guidance on what cosmetic claims sunscreens can make.

The industry respondents who supported Options 2 or 3 outlined that this will enable innovation and marketing advantage for sunscreen sponsors to distinguish their products from other sunscreens. Some industry respondents suggested different or additional permitted indications to be allowed for sunscreens as part of their response. Respondents representing health professionals and consumers expressed concerns that the implementation of Options 2 or 3 would result in consumer confusion leading to detrimental effects on sun protective behaviour.

The TGA considered all feedback received from the consultation.

1. Adoption of the 2021 Sunscreen Standard

While some health professional and consumer groups raised concerns that the new labelling requirements in the 2021 Sunscreen Standard for aerosol/spray pump pack sunscreens do not go far enough to address safety concerns associated with these goods, the TGA considers the new usage instructions will provide important information on the correct application of these goods that, if followed by consumers, should reduce the adverse events associated with these products. When /if the 2021 Sunscreen Standard is adopted, the TGA will continue to monitor adverse events to sunscreens in the marketplace and reassess if these measures are adequate as required.

In consideration of the potential regulatory impact for industry of imposing new testing requirements for sunscreens, and appropriate transition times, the TGA is developing an Impact Analysis which will be submitted to the Office of Impact Analysis by the end of 2023. The Impact Analysis will assist the Government to make a decision on the adoption of the 2021 Sunscreen Standard and the appropriate transition period. It is anticipated that the Impact Analysis and Government decision will be published early 2024.

2. Removal of the outdated exemption for sunscreens with less than SPF4

Given there were no objections raised in the consultation responses, we have received Government approval to proceed with the implementation of this proposal. The removal of the exemption provisions for sunscreens with less than SPF 4 from the Therapeutic Goods Regulations 1980 (the Regulations) is scheduled to occur on 1 January 2024 and will apply to all new sunscreen products released for supply from 1 January 2024.

Transition arrangements included in the Regulations will enable any sponsors who have stock in the market before 1 January 2024 to continue to supply those products for 3 years. From 1 January 2027 products with less than SPF 4 will not be able to be released onto the market with any product label claims relating to sun screening.

3. Clarification on sunscreen indications

Based on the majority of stakeholder support for the TGA’s current framework for sunscreens, the TGA will clarify in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021 when next updated, that listed sunscreens can only use therapeutic indications specified in the Determination for  use in sunscreens.

The TGA will also clarify what non-therapeutic claims (e.g., cosmetic claims) can be included on a sunscreen label in the next update to the Australian Regulatory Guidelines for Sunscreens.

From 18 April 2023 to 17 May 2023, we sought submissions from the public on scheduling proposals referred to the June 2023 meetings of the Advisory Committees on Medicines Scheduling and Joint Meeting of the Advisory Committee 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 47 submissions in response to the pre-meeting public notice for June 2023. The breakdown of the responses is provided below:

BISACODYL: A total of 9 submissions were received for bisacodyl, 6 in full support and 3 in opposition of the proposal. Of these submissions, 4 provided a written response which were all in support of the proposal.

OLOPATADINE: A total of 8 submissions were received for olopatadine, 3 in full support, 3 in partial support and 2 in opposition of the proposal. Of these submissions, 3 provided a written response 2 in partial support and 1 in opposition of the proposal.

LEAD: A total of 17 responses were received for lead, 14 in full support and 3 in opposition of the proposal. Of these submissions, 9 provided a written response, 8 in full support and 1 in opposition of the proposal.

IBOTENIC ACID: A total of 8 responses were received for azelaic acid, 3 in full support, 2 in partial support and 3 in opposition of the proposal. Of these submissions, 3 provided a written response, 1 in partial support and 2 in opposition of the proposal.

AMYGDALIN AND HYDROCYANIC ACID: A total of 36 responses were received for amygdalin and hydrocyanic acid, 22 in full support, 4 in partial support and 10 in opposition of the proposal. Of these submissions, 21 provided a written response, 12 in full support, 4 in partial support and 5 in opposition of the proposal.

The Delegates 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 5 October 2023.

In 2023, we consulted widely on potential changes to how we undertake product recalls in Australia as part of ongoing reforms. Our discussion paper asked a series of questions around 5 key themes:

• Increasing awareness and understanding
• Improving communication
• Better recall descriptions
• Improving sponsor letters and other recall documents, and
• Reporting progress with recalls

These themes aligned with aspects of the recall process that stakeholders were advising us required the most attention. The discussion paper sought responses about the proposed changes, as well as providing the opportunity for stakeholders to have their say about any other ideas.

71 separate responses were received in total.

The Consultation responses were published in June 2023. 62 of the 71 responses consented to appearing (or partially appearing) on the TGA Consultation Hub, with 9 responses not consenting to be published.

View submitted responses where consent has been given to publish the response.

The proposals which received the broadest stakeholder support related to improvements to the recall and stakeholder communication processes and our guidance material. Respondents recommended that we:

• reduce regulatory burden by limiting unnecessary steps in the process
• ensure recall letters and notices are easy to read and have the key information up front so customers and other end users know exactly what to do
• provide greater transparency on our processes, including clarity around the timing for releasing recall information and our process for assessing the hazard classification of recall actions
• update our recall document templates
• change the focus of the Customer Acknowledgement Form to a Customer Response Form and include modern options such as QR Codes and online survey links to improve customer response rates to some sponsor recall letters, and
• give sponsors the opportunity to review the content of our Early Advice Notices prior to us seeking feedback from impacted stakeholders about aspects of the recall action before it is agreed.

To support these recommendations, we have made changes to the recall processes which will now be implemented via a new version of our guidance document, the Uniform Recall Procedure for Therapeutic Goods (URPTG) Version 2.4, which has just been published on our website. The key reforms which have been implemented addressing the above recommendations are:

Process changes

• We have reduced regulatory burden by decreasing the number of recall progress reports from 3 to 2
• We have introduced more flexible reporting requirements for sponsor submissions of the 2 reports
• The number of steps in the recall procedure has been reduced from 11 to 10.
• The ‘Early Advice Notice’ process has been expanded to include additional stakeholders such as patient support groups and health professional guilds, where appropriate. We will give sponsors the opportunity to review the content. 
• For recall actions involving ‘therapeutic goods’ which are also ‘consumer goods’, we have provided new guidance on the ‘lead regulator’ role – either the TGA or the Australian Competition and Consumer Commission (ACCC).

Changes to improve clarity and readability of the URPTG

• The recall action templates have been updated so they are easier to read and with key information up front. They have been removed from the URPTG, and instead hyperlinks included to our website directing users to the most up-to-date versions.
• The process we follow for releasing recall information has been clarified providing greater transparency.
• Clarity on the use of the ‘Early Advice Notice’ process has been included in the updated URPTG.
• Several sections have been re-written to be more concise and readable, including the process for undertaking “immediate recalls” and conducting a risk analysis.
• We have reduced the URPTG by over 20 pages by removing outdated or repeated guidance.

What's next?

Our reform work continues. One of the most endorsed proposals from our consultation paper was the new recall terminology. We will implement this when several supporting IT infrastructure changes are made to our systems. When this occurs, the new terminology and further reforms will be included in a new update to the URPTG.

We will also review:

• if further improvements can be made to our communication strategies and
• whether our existing legislative recall powers are supporting effective recall processes.

We will provide further updates as our reforms progress throughout 2024.

Between 3 February 2023 and 3 March 2023, we sought submissions from the public on the Delegate’s interim decision on paracetamol. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

A total of 201 submissions were received in response to the Delegate’s interim decision. The breakdowns of the responses are shown below:

In support of the interim decision: A total of 9 responses were received in support, 6 of which contained written responses.

In partial support of the interim decision: A total of 33 responses were received in partial support, all of which contained a written component.

In opposition to the interim decision: A total of 159 responses were received in opposition to the proposed amendment, 136 of which contained written responses.

The Delegate considered all submissions prior to making their final decision on paracetamol. The final decision for paracetamol was published on 3 May 2023.

Between 3 February 2023 to 3 March 2023, we sought submissions from the public on the Delegate’s interim decisions on substances previously discussed at the November 2022 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.

A total of 12 responses were received through the consultation. A breakdown of the submissions can be found below.

Ivermectin: 7 responses were received, 2 supportive of interim decision and 4 opposed. Of these, 1 in full support of the interim decision, and 3 submissions in opposition contained a written component. 1 submission contained a written component without indicating support or opposition.

Brimonidine: 2 responses were received, 1 in support of the interim decision and 1 in opposition. Only the submission in support of the interim decision contained a written component.

Fexofenadine: 2 responses were received, with one response in support of the interim decision and one against. Only the submission in support of the interim decision contained a written component.

Ibuprofen: 6 responses were received, 3 in support and 3 in opposition of the interim decision. Of these, 2 submissions in support of the interim decision and 2 in opposition of the interim decision contained written components.

Melatonin: 5 responses were received, 2 in full support, 2 in partial support and 1 in opposition of the interim decision. Of these, 2 submissions in partial support and 1 submission in full support contained a written component.

Green tea extract: 5 responses were received, 3 in full support and 2 in opposition to the interim decision. Of these, 3 submissions in support contained a written component and 1 submission in opposition contained a written component.

Ethalfluralin: 2 responses were received, 1 in support and 1 in opposition of the interim decision. No written components were received.

Tigolaner: 1 vote was received in opposition of the proposed amendment without a written component.

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 3 MAY 2023.

From 5 January 2023 to 3 February 2023, we sought submissions from the public on scheduling proposals referred to the March 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 response.

We received a total of 10 submissions in response to the pre-meeting public notice for March 2023. The breakdown of the responses has been provided below:

CELECOXIB: A total of 6 responses were received for celecoxib 4 in full support, 1 in partial support and 1 in opposition of the proposal. Of these responses, 5 provided a written response, 4 in support and 1 in partial support.

BROMOXYNIL: A total of 3 responses were received for bromoxynil, 2 in full support and 1 in opposition of the proposal. Of these, the 2 responses in support of the proposal contained a written response.  

DIOXANE: A total of 6 responses were received for dioxane, 2 in full support, 1 in partial support and 3 in opposition of the proposal. Of these, 1 submission in support, 1 submission in partial support and 2 submissions opposed contained a written component.

AZELAIC ACID: A total of 4 responses were received for azelaic acid, 3 in full support and 1 in opposition of the proposal. Of these submissions, 2 responses in support of the proposal contained a written component.

The Delegates 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 12 July 2023.

We asked for feedback on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia. Feedback was sought on:

• changes to border controls for NVPs
• pre-market TGA assessment of NVPs against minimum quality and safety standards
• minimum quality and safety standards for NVPs
• clarifying the status of NVPs as ‘therapeutic goods’.

We received almost 4,000 submissions in response to the consultation. The respondents were:

• State and Territory Health and Education Departments
• health professional bodies
• public health associations
• university researchers
• pharmaceutical industry and peak bodies
• vaping manufacturers/importers
• vaping retailers, including convenience stores and petrol stations
• pro-vaping associations
• individual healthcare professionals
• the general public, including individual vapers, smokers and ex-smokers.

A large number of the submissions from the general public appeared to be campaign responses that advocated changing the current regulatory framework in which NVPs are regulated as prescription medicines (which was outside the scope of the consultation).

Changes to border controls

• TGA’s preferred option was to strengthen border controls by requiring importers to obtain an import permit and by closing off the personal importation scheme.
• All State and Territory governments supported tightening border controls for NVPs, with most also supporting closing the personal importation scheme and requiring import permits.
• Health professional bodies, public health associations, individual health professionals, university researchers and companies marketing prescription NVPs to Australian pharmacies overwhelmingly supported tightening border controls for NVPs.
• Many (but not all) of these groups also submitted that border controls should be placed on non-nicotine vaping products (which went further than the proposed option in the consultation paper).
• Individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations did not generally support any import controls.

Pre-market TGA Assessment of NVPs against a product standard

• TGA’s preferred option was to require pre-market TGA assessment of NVPs against a product standard specifying certain quality and safety requirements.
• Companies supplying to the prescription pharmacy market supported this approach, as did about half of State and Territory governments, half of health professional bodies and nearly half of individual health professionals.
• Nearly half of public health associations and health professional bodies proposed instead that all NVPs be registered in the Australian Register of Therapeutic Goods and opposed pre-market assessment as they were concerned it could be misinterpreted as TGA approval.
• A large number of individual vapers, vaping retailers, vaping manufacturers/importers and pro-vaping associations supported at least some regulation to ensure NVP quality and safety (but with NVPs regulated as consumer goods, instead of as prescription medicines).

Strengthening quality standards for NVPs

• There was strong support for TGA’s preferred option from State and Territory governments, health professional bodies, individual health professionals, public health associations and university researchers to strengthen Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 to introduce warning statements (although this was opposed by some), require pharmaceutical-like packaging, lower the maximum allowable nicotine concentrations, prohibit/restrict flavours and certain other ingredients and limit NVP volume and overall nicotine content.
• Many of these submissions also called for the imposition of similar controls on non-nicotine vaping products (this was outside the scope of the consultation).
• Many individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations proposed abandoning the prescription model and the TGO 110 (also outside the scope of the consultation), but nonetheless many in this category supported some regulation to ensure NVP quality and safety.
• There was significant support for banning disposable NVPs from all categories of submitters (including individual vapers), but some opposed this because of concerns a ban could affect accessibility for smoking cessation and because of the risks of using some alternative products.

Clarifying the status of NVPs as ‘therapeutic goods’

There was general support for the proposal to clarify that all vaping products containing nicotine are therapeutic goods from all categories of submitters except individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations.

The TGA has considered the submissions and is now providing advice to Government on possible options for reform. The Government is actively considering the TGA consultation and advice.

We asked for feedback on:

• whether health professionals, consumers and health systems are ready for dual labelling (displaying both the old and new ingredient name on medicine labels and related documents) to end for all affected ingredient names
• a proposal to transition medicine labels and PI/CMI documents to sole medicine ingredient names in a specific time frame (for names suitable for transition).

We received 36 submissions in response to this consultation. 23 of the responses included permission for publication. Respondents provided a range of opinions about the end of dual labelling with many supporting a transition period and for some ingredient names to remain dual labelled for longer. We appreciate all the valuable feedback we received.

We considered all feedback received before deciding on changes to the dual labelling transition to sole medicine ingredient names.

Changes to the dual labelling period for some dual labelled ingredient names

In response to the feedback we:

• Extended the dual labelling period for 2 years (until 30 April 2025) for the following ingredient names to give health professionals more time to become familiar with these names:
  • dosulepin (dothiepin) hydrochloride
  • hydroxycarbamide (hydroxyurea)
  • tetracaine (amethocaine)
  • tetracaine (amethocaine) hydrochloride
  • trihexyphenidyl (benzhexol) hydrochloride.
• Are not changing some dual labelled names to sole names. Labels of medicines supplied in Australia and included in the Australian Register of Therapeutic Goods (ARTG) must continue to display both the old and new ingredient name for the following:
  • alimemazine (trimeprazine) tartrate
  • mercaptamine (cysteamine)
  • mercaptamine (cysteamine) bitartrate
  • mercaptamine (cysteamine) hydrochloride
  • Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain).
• Are ending the dual labelling period for most dual labelled names (those not listed above) on 30 April 2023 as planned.

New transition periods to update medicine labels to sole names

We implemented two separate 3-year transition periods for medicine sponsors to update medicine labels to reflect sole names, depending on when names are suitable for transition. We will encourage medicine sponsors to update PI and CMI documents to reflect sole names to align with updated labels during the transition periods.

• The transition period for most dual labelled ingredients will start 1 May 2023, ending 30 April 2026. Affected medicines released for supply from 1 May 2026 must reflect sole names.
• The transition period for ingredients subject to an extended dual labelling period will start 1 May 2025, ending 30 April 2028. Affected medicines released for supply from 1 May 2028 must reflect sole names.

The transition periods are included in the standards for medicine labels (Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines) via the Therapeutic Goods Legislation Amendment (Standards for Labels—International Harmonisation of Ingredient Names) Order 2023.

More information on changes to medicine labels from 1 May 2023

Changes to medicine labels take time and appear gradually as new stock is distributed, and existing stock is sold, to support the medicine’s availability in the community. More information about dual labelling and transition periods is available on the TGA website, see: 

• Dual labelled medicines begin transition to sole medicine ingredient names soon 
• Dual labelled medicine ingredient names start the transition to sole names on 30 April 2023
• Understand ingredient names on medicine labels as they transition to show new names only.

From 1 December 2021, the way in which sponsors submit an application for consent to import, supply, or export a medical device that is non-complaint with the Essential Principles changed from a paper version to an electronic form hosted in the TGA Business Services portal (TBS). The TGA requested sponsor feedback on this new application process through a survey on the TGA Consultation Hub.

The survey was open for feedback for 12 months, from 1 December 2021 to 1 December 2022.

There were no submissions received through the TGA Consultation Hub. However, stakeholders provided feedback through other channels such as the Regulatory and Technical Consultative Forum for medical devices (RegTech Forum). Sponsors requested additional save and print functionalities.  

In response to the feedback received, the TGA introduced additional save and print functionalities for both draft and submitted forms.

The TGA will continue to implement reforms to improve regulatory processes for sponsors of medical devices.

Between 21 October 2022 to 24 November 2022 we sought submissions from the public on the Delegate’s interim decision with respect to the proposal to amend the Poisons Standard in relation to psilocybine and MDMA that was referred to ACMS #38 in June 2022. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

Psilocybine: Through the consultation portal we received a total of 3,442 public submissions with respect to the interim decision for psilocybine, including 1,758 with a written component. Out of the total number of submissions received for psilocybine, 2,586 were in opposition of the Delegate’s interim decision.

MDMA: We received a total of 3,403 submissions through the consultation portal with respect to the interim decision for MDMA, including 1,658 with a written component. Out of the total number of submissions received for MDMA, 2,523 were in opposition of the proposed interim decision.

The Delegate considered all submissions prior to making their final decisions on these substances. The final decisions for psilocybine and MDMA were published on 3 February 2023.

Between 21 October 2022 to 24 November 2022, we sought submissions from the public on the Delegates’ interim decisions on proposed amendments to the Poisons Standard - ACMS #38, ACCS #34, Joint ACMS-ACCS #31 – June 2022  which were published on 21 October 2022. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

A total of 9 submissions were received a breakdown of which can be found below:

Cetirizine: 4 total responses, 2 in support and 2 in opposition of the interim decision.
Budesonide: 3 total responses, 2 in support and 2 in opposition of the interim decision.
Apronal: 2 total responses, 1 in support and 1 in opposition of the interim decision.
Helional: 1 response received in opposition of the interim decision.
Hydroxypinacolone retinoate (HPR): 4 total responses, 2 in support, 1 in partial support and 1 in opposition to the interim decision.
MDMA and MDA nomenclature: 4 total responses, 2 in support and 2 in opposition of the interim decision.
Dichloromethane: 5 total responses, 3 in support and 2 in partial support of the interim decision.
Ipflufenoquin: 1 response in opposition of the interim decision

The Delegates considered all submissions prior to making their final decisions on these substances. The final decisions for substances other than psilocybin and MDMA were published on 20 January 2023 . The final decisions for psilocybine and MDMA were published on 3 February 2023.

We asked your feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’ which will replace the existing guidance ‘Australian medical devices guidelines: 35. Device-medicine boundary products’.

The guidance aims to assist sponsors and manufacturers understand how TGA regulates boundary and combination products that may not fit clearly within existing definition of medicines, medical devices or biologicals.

Thirty-one (31) responses were received from stakeholders, including sponsors, manufacturers, industry peak bodies, regulatory affairs consultants, transplant donation organisations, contract research companies and other health regulators.

Alignment of guidance with respondent’s understanding

Overall, a majority of respondents (55%, n=17) indicated that the draft guidance material aligns with their current understanding of medicines, medical devices, and biologicals.

Out of those respondents who disagreed (45%, n=14) on the alignment with their current understanding, most suggested examples that were not addressed in the draft guidance, and that there were products listed in Appendix 1 where:

• further clarification of the product, category or mode of action is needed,
• the rationale for the product category designation was not clear, or counter-intuitive, and
• the product category is not in alignment with international jurisdictions.

Products that are not in alignment with the definitions

Some respondents (24%, n=13) indicated that there were products on the market that were not aligned with the definition and product category mentioned in the draft guidance for example:

• products for lice on the head and body
• products for removal of warts
• corn and callus removal products
• oral care toothpastes
• products used to cleanse dentures
• throat lozenges
• sunscreens that work through creating a physical barrier (zinc oxide-based)
• compounded and uncompounded emollient & moisturising preparations for therapeutic use
• anticoagulation solution bags used during blood cell separation (apheresis)
• carbon crucible required to make Technegas
• alcohol swabs containing an active ingredient or medicine claiming use for cleaning skin only
• non-antibiotic-based antimicrobial catheter lock solutions sold separately from a catheter
• personal lubricants used during sexual activity
• douches (e.g., douche applicator, solution, applicator-solution combined)

Interim arrangements for change of product category

Out of those who responded (n=29) to the question, majority (67%, n=12) suggested that special, interim arrangements would be required to ensure continued supply of products if the product category was changed whereas, six respondents (33%) suggested interim arrangements would not be required. Remaining stated that the question is not applicable to them.

In general, respondents advised that the timing of interim arrangements would depend on requirements from the TGA.

Respondents raised several issues and challenges regarding transitioning of products to new categories including:

• manufacturers may not be able to provide the required regulatory evidence to support product inclusion under a new category,
• transitioning products supplied as a medical device to a medicine will be difficult, as these products will now need to be manufactured according to GMP requirements, and
• potential costs for industry might result in business decision to withdraw products from the Australian market.

There were several other suggestions provided by respondents to improve the draft guidance across the range of submissions. These included:

• harmonising with international definitions for pharmacologic, physical and metabolic means
• use of decision trees or tools to help sponsors decide product categories
• adding guidance on regulatory evidence required for combination products
• adding more:
  • information on boundaries between medicines, food and cosmetics, 
  • information explaining how TGA regulates and categorises boundary and combination products and the rationale for regulatory decisions,
  • information on regulation of biologicals and biological combination products,
  • information on excluded goods, kits that contains medicines and biologicals,
  • adding links to TGA guidance on reclassification of medical devices, and
  • examples of each of the categories.

There were suggestions to improve the list of boundary products indicating product categories in Appendix 1 of the draft guidance. These included:

• suggested changes to the list, clarifying or adding products and their categories,
• adding an additional column to the list that explains the rationale for why products are categorised as a medicine, medical device, biological or another product category,
• harmonisation with international jurisdictions where appropriate, with any differences clearly communicated,
• advising sponsors if there is any action required to accommodate the updated guidance,
• clarifying boundary and combination products by making greater use of powers under the Therapeutic Goods Act 1989 (the Act) to specify particular goods to be medical devices and to declare that a particular class of goods to not be medical devices.

In response to your feedback, we revised and published updated guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’ with several changes including:

• more information and examples on regulation of boundary and combination products,
• explanation on how TGA regulates and categorises boundary and combination products,
• links to additional TGA guidance that may help you decide your product category,
• TGA contacts for sponsors and manufacturers who are unsure about the category and regulation of their boundary and combination products,
• improving readability by moving detailed background information on the definitions of medicine, medical device and biologicals and differentiating terms to the end of the document into an Appendix.

We acknowledge your feedback on the list of boundary products indicating the category of therapeutic good in Appendix 1. In response, we removed the list of boundary products (Appendix 1) from the guidance to enable us to publish the updated guidance while we continue to address your feedback on the list. 

What is next

We are finalising an updated list of boundary and combination products (formerly Appendix 1 in the draft guidance) based on your feedback. We will notify you once the updated list is published on our website.

We are currently considering further targeted consultation on the list of boundary and combination products (formerly Appendix 1) to address your feedback and whether the updated list (formerly appendix 1) is sufficient to provide regulatory certainty, or if legislative changes would be required.

If legislative changes are proposed, the TGA will consult with stakeholders and consider transitional arrangements for potentially impacted stakeholders. We will continue to engage with you around any further changes.

We asked for feedback on potential regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels).

We sought feedback on:

• whether references to the TGA should be allowed in therapeutic goods advertising
• the class or classes of therapeutic goods, if any, that should be allowed to refer to the TGA
• options for what a reference to the TGA could look like
• options for how an authorised reference to the TGA may be used in advertising
• whether references to the TGA should be optional or mandatory for advertisers.

A total of 26 submissions were received from the therapeutic goods industry (sponsors, manufacturers and industry organisations), healthcare professional bodies, consumers, consumer representatives and advertising organisations.

Overall, there was limited support for broadly allowing references to the TGA in advertising.

Around half of the respondents expressed moderate support for some regulatory change however of those most were of the view that this should be limited to certain types of products only. Even among those supportive of regulatory change, there was concern about the potential for consumers to misinterpret and/or be misled about the meaning of the reference to the TGA.

Respondents also raised concerns about:

• potential costs for industry relating to label changes, and international harmonisation of labels
• potential to mislead consumers in relation to the level of evaluation the product had undergone if the scheme applied to products such as complementary medicines and class I medical devices
• the potential for an unfair advantage when one product included the reference to the TGA, and a competitor product did not (when both had been subject to the same regulatory processes).

A strong majority of respondents agreed that, should regulatory changes be implemented, use of references to the TGA should not be mandatory for advertisers.

Several respondents suggested that allowing references to the TGA could be most useful in less typical situations, such as the circumstances around COVID‐19 rapid antigen tests when they first became available for home-use. In this situation health professionals and consumers were in need of information to assure them that the particular product had been TGA approved for supply. This option would see the TGA issuing an authorisation to allow references to the TGA only in particular circumstances with limiting conditions (for example for a particular product type and with a specified reference).

Based on the outcomes of consultation, agreement was sought from the Government on the options.

The Government has decided to allow the TGA to authorise advertisers of certain products in certain circumstances to make reference to the TGA in advertising in response to public health needs. This will be determined on a case-by-case basis by the TGA.

There are existing legal mechanisms the Therapeutic Goods Act 1989 that allow this to be implemented. 

We asked for feedback on your experience searching for adverse events using the DAEN – medicines beta version. We developed this beta version to improve the performance and useability for users

There were 34 responses to the survey. Users self-identified as sponsors, health professionals, consumers, academic researchers and other stakeholders.

Most users (70%) preferred the beta version. They commented that it looks nicer, was faster to search for products and easier to find the desired information. Many users (60%) also found the graphs useful. They said the graphs give a simple picture of the results and help to understand the prevalence of adverse events.

Users told us their challenges while using the beta version:

• using the date selector
• limit on the number of rows available for data export
• some cases do not include age
• not able to locate the number cases where death was the reported outcome
• searching for cases without a trade name reported
• Sponsor needs for access to additional information not displayed in the DAEN – medicines to fulfil their pharmacovigilance responsibilities.

The beta testing period for the new DAEN – medicines is complete. The older version of the database has increasingly experienced performance issues and we have now removed links to that interface from the TGA website. This means that the new beta version of the DAEN – medicines is the only version available on the TGA website.

We have also updated our user guidance on the TGA website with search tips and information about search results, for example where cases may be missing details such as age. The DAEN – medicines shows cases where death was the reported outcome in the Search summary counter and the Medicines summary. We also provide information on deaths following COVID‑19 vaccination in our COVID-19 vaccine safety reports.

To support sponsors accessing information needed for their medicine safety responsibilities, we are also developing a secure, self-serve portal where they can access deidentified data related to their medicines. You can find more information on this at Improving access to medicine adverse event data.

We noted that some researchers and academic users seek to download more data than the 150,000 export limit. The complete data set can now be exported using filters to split the data into separate export files.