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.
We asked for feedback on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia. Feedback was sought on:
We received almost 4,000 submissions in response to the consultation. The respondents were:
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
Pre-market TGA Assessment of NVPs against a product standard
Strengthening quality standards for NVPs
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:
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:
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 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:
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 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:
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:
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:
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.
Between 14 September 2022 and 14 October 2022, we sought submissions from the public on potential options to amend the Poisons Standard with respect to paracetamol, following an independent expert report on the risk intentional self-poisoning with paracetamol. The matter was referred to the November 2022 meeting of the Advisory Committee on Medicines Scheduling. Respondents were given the choice to indicate their preferred option/s across 6 categories of access or purchasing controls.
A break-down of the votes attributed to the proposed options can be found by following the links on the Published responses page.
The Delegate considered all submissions prior to making their interim decision on amendments to the scheduling of paracetamol. The interim decision was published on 3 February 2023. Following another round of public consultation final decisions for these substances will be published in April 2023.
Between August and October 2022, the TGA sought feedback on the proposed intent for the Australian UDI system. The consultation principally sought feedback on five key areas:
84 submissions were received, with most representing medical device sponsors or manufacturers. Other respondents included industry peak bodies, health professionals, a clinical quality registry, a state health organisation, and other international governments. No submissions were received from General Practitioners, export-only Australian manufacturers, or consumers.
Respondents provided wide-ranging comments and suggestions across all questions. Overall, the responses demonstrate continued strong support for the Australian implementation as well as many valuable comments and suggestions on the implementation approach and phasing.
The TGA appreciates all the feedback and thanks all respondents.
We have analysed all responses and the results will inform future policy decisions by the Australian Government. In line with your strong feedback about ongoing engagement, the TGA will continue to work closely with stakeholders as we progress the implementation.
The Therapeutic Goods Administration (TGA) sought feedback to determine if the Product Information (PI) is a necessary package insert in boxed injectables administered by healthcare professionals, or whether provision of the PI electronically on the TGA website is sufficient.
Fifty seven (57) responses were received from various stakeholder groups comprising healthcare professionals, healthcare groups, interested medicine consumers, pharmaceutical companies, and governing bodies.
The feedback we received is summarised below.
We are using the feedback received to develop options for further consideration to shape regulatory reforms and policy, noting that further consultations may be required with more user groups and stakeholders. Implementation of some options may require government approval (regulatory change) and/or parliamentary approval (legislative change), and we will present these to the Government for consideration.
Consultation responses are published based on consent provided by respondents in line with the TGA policy. Please see related attachment 'Responses to the Product Information (PI) as a package insert consultation- consented for publishing only'.
Between 1 September 2022 to 29 September 2022, we sought submissions from the public on scheduling proposals referred to 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 30 responses were received through the consultation. A breakdown of the submissions can be found below.
Ivermectin: 17 responses were received — 12 supportive of the proposed amendment and 5 opposed. All contained a written component.
Brimonidine: 3 responses were received, all of which were supportive of the proposed amendments but did not contain a written component.
Fexofenadine: 2 responses were received — one (1) supportive of the proposed amendment and one (1) opposed. Both submissions contained written responses.
Ibuprofen: 5 responses were received, all with a written component — one (1) supportive of the proposed amendment and 4 opposed.
Melatonin: 5 responses were received, all with a written component — 4 supportive of the proposed amendment and one (1) opposed.
Green tea extract: 7 responses were received, all with a written component — one (1) supportive, 3 partially supportive and 4 opposed to the proposed amendments.
Ethalfluralin: One (1) written submission was received that was supportive of the proposed amendment.
Tigolaner: No responses were received regarding the proposed amendment.
The Delegate considered all submissions prior to making their interim decisions on these substances. The interim decisions were published on 3 February 2023. Following another round of public consultation final decisions for these substances will be published in April 2023.
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:
A total of 9 submissions were received in response to this consultation. All submissions that gave permission to be published on the TGA website are available through the ‘View submitted responses’ link below.
The TGA received:
The responses varied in stance and recommendations, however the majority of respondents from the complementary medicines industry did not support the proposals, with many suggesting rewording or clarification of the warning statement. Concerns were raised about the length and complexity of warning statements, the reference to general liver injury symptoms which can potentially cause confusion among consumers, the lack of clearly established causality between valerian use and liver injury, and lack of similar warning statements in international regulation.
The feedback and recommendations provided by respondents were taken into consideration, and the proposed changes have been finalised. The final changes incorporate variation compared to the original proposals.
The final changes will commence on 1 March 2023. A 12 month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2024.
From 29 April 2022 to 27 May 2022, we sought submissions from the public on scheduling proposals referred to the June 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.
We received 6,766 responses, including 2,457 with written submissions, the majority of which commented exclusively on the proposals relating to MDMA and psilocybine. A tally of the survey responses supporting, partially supporting, or opposing each of the proposed amendments to the Poisons Standard can be found on the Published public submissions page.
In the written submissions, the main points in support for the proposed amendments for MDMA and psilocybine were: restricted use of the substances for treatment-resistant mental illnesses have been approved abroad; the abuse potential of the substances when prescribed and used within an appropriate medical setting and supplied by trained professionals is low; and there is potential for significant benefits of the medicinal use of the substances to treat chronic treatment-resistant mental illnesses for which patients are urgently seeking new treatment options.
The main points in opposition were: insufficient new evidence has been provided of the therapeutic value of the substances to that already previously considered by the Advisory Committee on Medicines Scheduling and the decision-maker; and although there are some phase 3 clinical trials underway, more evidence from such trials is required regarding safety, efficacy and potential for abuse and misuse before it can be considered again for down-scheduling.
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 21 October 2022.
All submissions that are suitable for publication do not have confidential information and have been published if the author gave consent to do so.
Between 10 March 2022 to 11 April 2022, we sought submissions from the public on the proposed interim decisions which followed the November 2021 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 41 responses for the interim decision consultation, 31 with written components. The majority of responses were in relation to the proposal for cannabis and THC.
The number of votes in opposition for the proposal for cannabis and THC was 25 and 5 fully supportive of the proposed interim decision.
A total of 13 responses were received for meloxicam, 8 in opposition and 5 in full support.
For astrodimer, a total of 13 responses were received, 5 in opposition, 1 in partial support and 4 in full support of the proposed interim decision.
There was a total of 13 responses for choline salicylate, 5 opposing the interim decision, 2 in partial support and 3 in full support.
A total of 9 responses were received for flurbiprofen, 4 in opposition, 1 in partial support and 4 in full support of the interim decision.
For cis-jasmone a total of 8 responses were received, 3 in opposition, 1 in partial support and 4 in full support.
There was a total of 7 responses received for the interim decision in relation to chromates and chromium trioxide. Of these 3 were in opposition, 2 in partial support and 2 in full support.
The Delegate considered all submissions prior to making their final decisions on these substances. The final decisions for substances other than cannabis and THC were published on the 23 May 2022. Following further advice from independent experts, the final decision for cannabis and THC was published on 15 November 2022.
The 2022 follow up consultation sought stakeholder input into four core challenges for the repurposing of medicines:
Twenty-seven (27) responses were received from four key stakeholder groups: patients and patient groups, health professionals, academia, and the pharmaceutical industry. The feedback we received can be summarised in four areas.
Identifying potential candidates
The Department is now using this and other feedback to shape regulatory reforms and policy. Consultation with internal and external stakeholders continues. Implementation of some options may require government approval (regulatory change) and/or parliamentary approval (legislative change), and the Department will present these to the Government for consideration.
We asked for feedback on a proposed priority review pathway for assessment of certain novel and life-saving biologicals. The proposal was to introduce a formal pathway for biologicals with shorter time from submission to ARTG inclusion, in alignment with the existing priority pathway for medicines.
Feedback was sought on:
We received 25 submissions in response to the consultation, 21 were received through Citizenspace and 4 were received through email. The respondents were from industry organisations and peak bodies, health professionals or heath professional organisations, consumer groups and individuals.
All respondents supported introduction of the proposed priority pathway, noting, this is a step in right direction and will improve timely access to lifesaving products and align biologicals with medicines.
There was general support for the proposed eligibility criteria with 72% respondents supporting it, but some comments raised concerns on the suitability of criteria for all classes of biological products, clarity around the terminology used, and the need for alignment with overseas regulators.
The proposed process for determination, timeframes, and the need to publish outcomes of determination decisions, decision summaries and AusPARs were supported by the respondents.
We considered all submissions and have made minor changes to the wording of the eligibility criteria to address some of the concerns.
We have finalised the priority pathway for biologicals and made necessary legislative changes to enable its implementation. The pathway is now operational and can be utilised by Sponsors. We have provided necessary guidance material on TGA website to assist sponsors interested in using this pathway.
TGA will continue to work with PBAC and MSAC to align the accelerated ARTG inclusion of biologicals through the priority pathway with reimbursement schemes.
We asked for feedback on proposed new functionality that would allow sponsors to view and export relevant de-identified medicine adverse event data from TGA systems, using their existing sponsor authentication process (e.g. TGA Business Systems login credentials). We specifically asked about:
We received 44 survey responses from sponsors and research organisations spanning prescription, non-prescription and complementary medicines, and medicinal cannabis products. Respondents broadly supported the initiative and provided valuable feedback on our proposals.
Sponsor access to medicine adverse event data
Almost all respondents stated they rely on the public Database of Adverse Event Notifications (DAEN)-medicines and direct email requests to TGA to obtain information on medicine adverse events. Most respondents import this data into their company pharmacovigilance systems to fulfill their TGA pharmacovigilance responsibilities and to supplement their international reporting obligations.
For the proposed new functionality respondents wished to access the same information they receive through their existing mechanisms. They also requested access to additional data, such as data to assist in identifying duplicates, information about the seriousness of an adverse event, concomitant use of medicine and medical conditions, and case type (e.g., post-market, Special Access Scheme (SAS) or under clinical trial).
Viewing/extracting adverse event data held within TGA systems
Most respondents supported the use of the proposed functionality to view adverse event data that relates to both their own products and other products which have the same active ingredient. A large majority stated that they wish to extract data directly into their pharmacovigilance systems. Although it is not mandatory for sponsors to seek historical adverse event cases, many requested access to the full range of available mapped sponsor-product data. Many respondents indicated that automating the ability to extract data would reduce regulatory burden for sponsors in meeting their pharmacovigilance responsibilities. The majority preferred receiving adverse events data via E2B R3 ICSR message, with a flat .CSV file being the second preferred option. Other file format options were pdf and xml.
Most respondents agreed that agents (i.e. nominated officers external to the company who have permission to undertake regulatory correspondence with TGA on behalf of the sponsor) should have the same access as sponsors to this data.
EDI Gateway
The majority of respondents stated they currently submit cases through the EDI Gateway, with almost all eager to receive data through this functionality. Some respondents who have not yet implemented EDI functionality also showed interest in future adoption to reduce manual processes.
Where use of EDI was not adopted, respondents stated this was due to concerns over lack of expertise in required standards, perceived complexity of the functionality, resource constraints, low volume of reportable cases and need for consistent formats with global partners.
E2B R3 – Current behaviour and transition
Most respondents currently submit case reports to overseas regulators using the ICH E2B(R3) standard and almost all respondents supported a voluntary transition to use of this standard as an input channel. Where not supported, reasons included concerns over company size, need for resources, and complexities involved in adoption.
Most respondents were eager to adopt the updated standard within a year’s time, with the majority stating they could transition within 6 months. Most other respondents are willing to transition within 2 years, with a small proportion stating they would require 3-5 years for implementation.
Product terminology
WHO drug dictionary was the most commonly used terminology for coding product information in sponsors’ internal systems and cases submitted in the E2B R3 format. Some respondents stated they use extended EudraVigilance medicinal product dictionary (XEVMPD) and bespoke terminology.
Some respondents are already using ISO IDMP standards for submitting cases in the E2B R3 format, with a few also planning to adopt these in the near future.
We are considering your feedback
Thank you to everyone who responded to the survey. The feedback received will inform IT requirements for the proposed functionality, as well as our privacy impact considerations. Guidance for sponsors about this new functionality will be published as part of implementation.
Other improvements to how we share adverse event data
We are currently working on restoring the ability for users to extract and save search results from the DAEN‑medicines, as well as other improvements to how information is displayed on‑screen. These improvements are expected to be available on the TGA website in the coming months.
Between 12 October 2021 to 11 November 2021, we sought submissions from the public on the interim decisions made for the substances discussed at the June 2021 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 2 responses, each with a written component.
The Delegate of the Secretary of the Department of Health and Aged Care that is responsible for chemicals scheduling considered all submissions prior to making a final decision on these proposals. The final decisions on the proposed amendments to the Poisons Standard were published on 19 January 2022.
Between 13 October 2021 to 11 November 2021, we sought submissions from the public on the interim decisions made for the substances discussed at the June 2021 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 2 responses, one with a written component. One response addressed the interim decisions for all items, and the second submission voted and wrote regarding the interim decisions relating to ethanol and isopropanol in hand sanitisers, and eugenol.
The Delegates of the Secretary of the Department of Health and Aged Care that are responsible for medicines and chemicals scheduling considered all submissions prior to making final decisions on these proposals. The final decisions on the proposed amendments to the Poisons Standard were published on 20 December 2021.