We asked, You said, We did

Below are some of the issues we have recently consulted on and their outcomes.

We asked

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.

You said

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.

We did

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.

We asked

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.

You said

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

We did

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

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

You said

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

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

Users told us their challenges while using the beta version:

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

We did

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.

We asked

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.  

You said

A break-down of the votes attributed to the proposed options can be found by following the links on the Published responses page.

We did

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.

We asked

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.

You said

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.

  • The hard copy PI may be valuable for the first year or two for new injectables
  • Most respondents noted that some sections of the PI are more useful than others
  • Some respondents noted a shorter PI would be useful to ensure safety and minimise waste
  • In the hard copy PI, respondents noted that administration information is easy to find without the need of technology
  • The respondents noted that the hard copy PI is reliable, trusted and is available without internet access
  • Most respondents expressed concerns regarding the font size of the hard copy PI being too small to read
  • A QR code/2D barcode linked directly to the PI may be useful as the hard copy may not be the most up-to-date source
  • Some respondents noted searching for PIs online can be difficult and a direct link may  be more useful for accessing the most up-to-date PI
  • There was concern about the lag time between updated safety information being added to the PI and that information being included in the hard copy PI
  • Some respondents noted it was convenient to have the hard copy available in the medication trolley for ease of access during administration rather than referring to a computer
  • Some respondents noted that the hard copy PI included in the injectable box may reduce the risk of administration errors
  • Respondents noted that there should be considerations made for settings that have barriers to electronic resource accessibility, for example in some rural and remote areas or rural aged care facilities
  • Respondents noted that healthcare professionals are trained in administering injectables and have access to medicines information from sources other than the hard copy PI
  • Some respondents noted that an electronic PI would allow for harmonised packaging with other jurisdictions
  • Some respondents noted a larger box is required to accommodate the hard copy PI, which may result in increased transport and storage cost of the injectable
  • Respondents noted the usefulness of the hard copy PI however, also acknowledged the high environmental impact of the paper usage
  • Several respondents requested to broaden the scope of the consultation from boxed injectables to include all injectable products administered by a healthcare professional

We did

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'.

We asked

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.

You said

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.

We did

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.

We asked

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. Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus, and Larrea tridentata.
  2. Liver injury associated with Valeriana officinalis

You said

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:

  • 3 responses to the proposed update to the warning statement for Chelidonium majus and Larrea tridentata.
  • 9 responses to the proposed liver injury warning statement for Valeriana officinalis.

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.

We did

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.

We asked

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.

You said

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.  

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 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. 

We asked

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.

You said

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.

We did

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. 

We asked

The 2022 follow up consultation sought stakeholder input into four core challenges for the repurposing of medicines:

  • address commercial and intellectual property issues;
  • identify the best candidates for repurposing;
  • prioritise candidates; and
  • approach and incentivise the market.

You said

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.

Overcoming commercial constraints and addressing intellectual property issues

  • Incentives will need to counter costs involved in preparing a submission, fees, the burden of post-market surveillance and supply guarantee obligations.
  • Collaborative submissions would require clear, fair, and appropriate incentives for all involved. Responsibilities and liabilities would need to be clearly determined. The Department will also need to consider anti-competition issues.
  • Clarity regarding data sharing and ownership, regulatory, manufacturing, and operational responsibilities, as well as cost sharing will be required when repurposing off-patent medicines.
  • Extension of data or market exclusivity regimes to the repurposed indications may discourage ‘game play’ and strategic timing of new indications to maximise market monopoly through ‘rolling’ periods of data exclusivities.

Identifying potential candidates

  • The Department should make patient voice a priority.
  • Rare diseases and unmet need should be focus areas.
  • Candidates may be identified in current clinical practice documentation such as clinical guidelines and Standards of Care.
  • National and state organisations such as the Council of Australian Therapeutic Advisory Groups (CATAG), as well as specialist medical colleges and compassionate programs may be able to identify potential candidates.
  • Involvement of hospital networks and pharmacies in sourcing pharmacy compounding records, retrospective medication charts and patient records may enable a demand driven model for identifying potential candidates.
  • Horizon scanning for new products that might enter the market and meet unmet patient needs should be conducted in parallel with the repurposing process.

Prioritising candidates

  • Real-world data insights should be considered early in the process of prioritisation.
  • Candidate medicines that have the largest impact on patient care and quality of life should be a priority.
  • An expert advisory panel with representation from all stakeholders and expertise in all the different facets of the repurposing process should be responsible for prioritising candidates.
  • Safety, efficacy, commercial feasibility, and other factors should be considered early in the process for efficient use of time and resources.
  • Clear guidance and criteria should be set by the Department.
  • If the Department chooses to set priority therapeutic foci, National Health Priority Areas (NHPA) should be considered, with flexibility where unexpected changes arise due to shortages, commercial decisions or delisting.
  • The TGA could publish a list of indications prioritised for repurposing to attract sponsors of off-patent product who have interest and capability to pursue a new indication even if they do not currently sponsor the candidate product in Australia.
  • The current EMA pilot of repurposing medicines could be a model for the prioritisation of candidates in Australia.
  • The Government should be transparent about how the decisions are made, which indications may be considered, and the outcomes of applications.

Encouraging sponsors to apply for regulation and reimbursement

  • Fee waivers and exclusivity periods of sufficient length (e.g., up to 5 years) may provide adequate financial returns to cover the ongoing cost of pharmacovigilance activities and financial and legal obligations for local sponsors.
  • A streamlined process with simpler data requirements would reduce the burden on sponsors of applying for the repurposed indication.
  • Detailed guidance on how the TGA and PBAC will evaluate repurposing applications would be beneficial.
  • Active negotiation such as pre-submission meetings between sponsors and government as well as parallel evaluations by the TGA and PBAC may help clarify minimum standards for approval, garner mutual commitment and expedite the process.
  • An initial feasibility assessment of an acceptable price would allow sponsors to explore commercial incentives, and consider international pricing risks.
  • PBS exclusivity rather than regulatory exclusivity may be attractive to some sponsors.
  • Sponsors should be allowed ample time (e.g. up to 3-4 months) to consider their interests and decide to take on a repurposing application.

We did

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

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:

  • whether you support the introduction of a priority review pathway for biologicals
  • the proposed eligibility criteria for priority determination.
  • the proposed process for priority determination.

You said

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 did

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

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:

  • The type of medicine adverse event data sponsors would wish to view and/or extract from TGA’s Adverse Events Management System (AEMS) and their preferred format.
  • Sponsors’ views on using the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Enterprise to Business (E2B) R3 standard  for submitting and receiving adverse event reports via the secure Electronic Data Interchange (EDI) service.

You said

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 did

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.

We asked

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.

You said

We received 2 responses, each with a written component.

 

We did

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.

We asked

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.

You said

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.

We did

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.  

We asked

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 meeting of the Advisory Committee on 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 2 responses, both with written components. One submission provided comments on lead acetate alone, and the second submission provided their views on the interim decisions relating to lead acetate, 6-methoxy-N2-methyl-2,3-pyridinediamine and, 2-amino-5-methylphenol.

We did

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 20 December 2021.  

We asked

Between 30 September to 1 November 2021, we sought submissions from the public on the interim decisions made for the substances discussed at the June 2021 meeting of the Advisory Committee on Medicines Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

You said

We received 24 responses, 20 with a written component.

We did

The Delegate of the Secretary of the Department of Health and Aged Care that is responsible for medicines 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 20 December 2021.

We asked

Between 30 September 2021 to 1 November 2021, we sought submissions from the public on the interim decisions made for the substances discussed at the June 2021 meeting of the Advisory Committee on Medicines Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

You said

We received 3 responses, all with written components which contained comments pertaining to amygdalin and hydrocyanic acid and ibuprofen. No submissions were received with respect to bufexamac.

We did

The Delegate of the Secretary of the Department of Health and Aged Care that is responsible for medicines 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 20 December 2021.  

We asked

Between 6 September 2021 to 7 October 2021, we sought submissions from the public on scheduling proposals referred to 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.

You said

We received a total of 402 responses, 284 with written components. The majority of submissions were in relation to the proposal for meloxicam.

The number of votes in opposition of the proposal for meloxicam was 305, there were 3 votes partially supporting the proposal and 21 in full support. Of those in opposition, 97% indicated they were health professionals and/or researchers, predominately from the veterinary industry.

The consultation for cannabis and THC received a total of 116 responses. Of these responses, 11 were opposed, 16 were in partial support and 79 votes were in support of the proposal. The votes in support of the proposal were mainly from responders who had indicated that they were health professionals and researchers.

The total number of votes received for choline salicylate was 28. There were 7 votes in opposition 6 votes in partial support and 15 votes fully supporting the proposal.

There was a total of 23 votes in response to the proposal for cis-jasmone. The number of votes in opposition was 4 followed by 2 votes in partial support and 17 votes fully supporting the proposal.

For astodrimer, a total of 41 votes were received. The votes in opposition and in full support were even, both with 17 votes each, and the remaining 7 votes in partial support for the proposal.  Of the votes in opposition, the majority of respondents indicated that they were health professionals/researchers.

There was a total of 35 submissions for flurbiprofen, 13 in opposition, 4 in partial support and 18 in full support of the proposed amendments.

A total of 21 votes were received with respect to chromates and chromium trioxide. Of these votes, 6 voted in opposition, 2 in partial support and 13 in support of the proposed amendments.

We did

The Delegate considered all submissions prior to making their interim decisions on these proposals. The interim decisions on the proposed amendments to the Poisons Standard were published on 10 March 2022.

We asked

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. Allergen statement for mollusc-derived ingredients.
  2. Peripheral neuropathy associated with lower dose vitamin B6.
  3. Risk to infants from nasal use of benzalkonium chloride.
  4. Artemisinin and pregnancy risk.

You said

A total of 20 submissions were received in response to this consultation. All submissions that gave permission to be published on the TGA website are available through the ‘View submitted responses’ link below.

The TGA received:

  • 6 responses to the proposed mollusc warning statement,
  • 15 responses to the proposed changes for vitamin B6 ingredients,
  • 5 responses to the proposed changes to benzalkonium, and
  • 8 responses to the proposed warning statement for artemisinin-containing ingredients.

There was general agreement for the proposed mollusc label statement and changes to benzalkonium for use in nasal sprays, whereas the submissions concerning vitamin B6 and artemisinin varied in stance and recommendations.

We did

The feedback and recommendations provided by respondents were taken into consideration, and the proposed changes have been finalised. The final changes incorporate some variation compared to the original proposals.

The final changes will commence on 1 March 2022. A 1 year transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2023.

We asked

We asked for feedback on potential refinements to the existing regulatory requirements for patient information materials, including the content and form of the materials and exempt devices.

You said

A total of 34 submissions were received with more than half of the submissions from health care professionals and hospitals who are responsible for providing information to patients. Submissions were also received from consumers, professional health related societies and the medical device sector.

Almost all respondents, including the consumers, agreed with the proposals for providing information in a range of formats. This would allow information to be recorded in electronic formats such as electronic patient records and MyHealth records. Although, several respondents considered that regardless of how the information is kept, patients should also have the option to receive a hard copy.  Most were in favour of flexibility in the way information is provided. There were also suggestions for providing patient information materials in different languages and in audio form. The medical device industry respondents noted that electronic formats would reduce cost and some health care providers considered that costs are offset by benefits. However, there were several concerns raised about the burden on hospital staff and administration times if the system is too demanding or complex.

The majority of respondents agreed that it is unnecessary to provide patient implant cards if the device is going to be absorbed by the body within a certain timeframe. Those that stated they did not agree had concerns over delayed reactions to such implants. The suggested timeframes varied from days to 2 years, but the majority of those who responded opted for periods of 3 to 6 months.

The strong majority of respondents agreed that it is unnecessary to provide patient implant cards for pedicle screws, given that many types of screws could be used in one surgery.  There were suggestions that a system implant card is sufficient (that covers all implanted devices from one system), or that a generic patient information leaflet could be provided. In general, the responses indicate that it is unnecessary to provide patient implant cards for each screw or component, but the requirement for a patient information leaflet should be retained.

Although only a few respondents had comments on other devices which could be exempt from the requirements, there was strong representation for exempting reloads with staple line reinforcement, sutures with pledgets, and pledgets alone from requiring patient implant cards. There was also a recommendation to ensure alignment with the European requirements by exempting spinal rods, suture anchors, wedges (augments), laminar hooks, non-expandable cages, interspinous spacers, and bone screws.

There were also some questions about certain devices such as coronary stents and dental crowns, which indicated that there was still some confusion about the regulatory requirements for these devices.

It was noted that there was a need for increased communication about the implementation including education for hospitals, procurement officers and clinicians in relation to the provision of these materials.

We did

Based on the outcomes from the consultation, agreement will be sought from the Government to consider refinements to the Regulations. These refinements would:

  • allow more flexibility in how patient information materials can be provided including in a range of formats such as electronic format and at either pre or post surgery (i.e. not necessarily supplied with the device in the packaging);
  • exempt devices absorbed by the body within a defined time period from the requirement for a patient implant card but maintain the requirement for a patient information leaflet;
  • exempt pedicle screws from the requirement to have a patient implant card. The requirement for a patient information leaflet will be retained, but could be incorporated into a system patient information leaflet where appropriate; and
  • create the power for a TGA delegate to consider exempting other devices where clinically appropriate to ensure alignment with Europe, where possible.

Guidance documents will be updated to address other concerns raised in the consultation. Continued education will also be provided, including clear messages to relevant groups such as hospitals, surgeons, clinicians and procurement officers in relation to the implementation of patient information materials.          

Guidance will be further updated following a decision from the Government on the proposed refinements.