We asked, You said, We did

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.

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

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

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

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

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

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

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

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

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

Specific devices that should be provided with an eIFU

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

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

Availability of eIFU

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

Accessibility and storage of eIFU

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

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

Manufacturers’ requirements for supply of eIFU

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

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

We asked: 

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

You said: 

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

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

ALLYL ESTERS: No votes were received for allyl esters.

GLYOXYLIC ACID: No votes were received for glyoxylic acid.

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

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

We did: 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CAMPROMORELIN: No submissions were received.

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

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

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

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

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

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

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

We asked them:

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

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

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

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

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

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

Impacts of medicine shortages and discontinuations

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

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

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

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

Medicine shortages most frequently mentioned 

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

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

Opportunities for improvement

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

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

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

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

Other matters relating to the supply of medicines in Australia

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

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

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

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

Summary of challenges and barriers

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Recommendations for reforms 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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.

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.