We Asked, You Said, We Did

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

We asked

We asked for feedback on a proposed standard for nicotine vaping products that have not been assessed by the TGA (unregistered nicotine vaping products). While it is possible that in the future there may be nicotine vaping products that have been assessed and approved by the TGA as medicines, we expect that in the meantime there will be a significant number of prescriptions written for unapproved goods for smoking cessation. We proposed a set of minimum safety and quality requirements for unregistered nicotine vaping products to support health professionals and consumers in knowing what is in the product being prescribed and used and to reduce the risks of accidental poisonings.

In this consultation we also asked for feedback on a proposal to exempt those unregistered nicotine vaping products that meet the requirements in the proposed standard from having to meet certain other default standards in the European Pharmacopoeia and the United States Pharmacopeia. 

You said

We received 103 submissions in response to the consultation, including from research, government, health professional, consumer and industry organisations, as well as from individual consumers. There was broad support for the creation of a standard for unregistered nicotine vaping products. Respondents provided a range of views and suggestions to improve the standard, including:

  • more strict labelling requirements, such as the need for a consistent measure of the concentration of nicotine in the product and clear rules about which label warning statements (e.g. ‘KEEP OUT OF REACH OF CHILDREN’, ‘Avoid contact with eyes’, ‘Avoid contact with skin’)
  • the need for accurate labelling of nicotine concentration or content in the product
  • information about additional ingredients associated with known inhalation harms
  • diverse views on whether the standard should specify limits on nicotine concentration, container volume and flavours
  • a preference that the standard also apply to products that may be listed on the Australian Register of Therapeutic Goods (ARTG) in the future as ‘Export Only’ medicines
  • suggestions about different types of information manufacturers and others should be expected to hold about the products
  • requests for the regulation of vaping devices.

Thank you to everyone who provided feedback and helped in the development of the standard.

We did

In response to this feedback, the standard includes updated labelling requirements for nicotine concentration (including requiring nicotine concentration to be specified in mg/mL and warning statements to be provided), the prohibition of three additional ingredients with established inhalation risks, record keeping requirements for sponsors, a limit of nicotine concentration of 100 mg/mL in products and a requirement for actual nicotine concentration/content of a product to be within +/- 10% of what it says on the label. The standard has also been expanded to cover ARTG-listed ‘Export Only’ products.

Although the standard does not restrict the flavours of nicotine vaping products (other than those containing prohibited ingredients) or container sizes, it is important to remember that these factors, and others, are restricted by the person’s prescription. This allows the prescribing health professional and patient to work together to make sure that the right product is supplied to support nicotine and smoking cessation.

The new Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 was published in May 2021 and comes into effect on 1 October 2021. This standard will apply to all unregistered nicotine vaping products in Australia (including compounded and clinical trial products and ARTG-listed as ‘Export Only’ products).

The Therapeutic Goods (Exempt Monographs) Determination 2021 (“the Determination”) was made at the same time as the standard. The purpose of the Determination is to exempt unregistered nicotine vaping products from certain pharmacopoeial standards that automatically apply to therapeutic goods.

To help explain the new requirements we have published draft guidance to support this standard. We expect to finalise this guidance in June 2021.

We asked

Between September and December 2020, the TGA sought feedback to help inform the planning and design of the implementation of identifiers for Australian medical devices and the establishment of the Australian Unique Device Identification database. This is the second consultation and builds on the findings from the first. Specifically the TGA sought feedback on:

  1. What are the benefits of an Australian UDI System across the broader health system?
  2. Should the first phase of an Australian implementation be limited to a small number of high-risk devices?
  3. If the Australian implementation fully aligns with the IMDRF guidance, what will the impact be?
  4. What mechanisms should be considered for submitting the UDI data to the TGA?
  5. What might the benefits be for implementing the EU Basic UDI-DI in Australia?
  6. What are the benefits of the Global Medical Device Nomenclature (GMDN) and how is it being used?

You said

Ninety responses were received with sixty percent of responses from medical device manufacturers and/or sponsors. The remaining respondents represent most other segments of Australia’s healthcare system, however it was noted that no submissions were received from Registries or General Practitioners.

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 did

We have analysed all responses and the results will inform Australian Government policy decisions going forward. In line with your strong feedback on ongoing engagement, the TGA will continue to work closely with stakeholders as we progress the implementation.

We asked

Public consultation on the Delegate’s interim decision on nicotine scheduling was held between 23 September and 12 November. The interim decision and public consultation relate to a delegate-initiated proposal referred to the June 2020 meeting of the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25).

You said

We received 2385 submissions in response to the public consultation, including seven submissions that were received offline. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback that we received.

We did

The Delegate considered all submissions prior to making the final decision on nicotine scheduling. The final decision was published on 21 December 2020 on the TGA website.

We asked

We asked for your feedback on the new ARPANSA Standard for Limiting Exposure to Radiofrequency Fields – 100 KHz to 300 GHz (RPS S-1) because we want to make sure that the standard is fit for purpose and provides clear guidance to industries and regulators to ensure the safety of Australian workers and the general public including people of all ages and health status.

You said

We received 61 submissions from a range of stakeholders, including health authorities, scientists, academic bodies and members of the general public. There were a range of technical comments, questions, and suggestions, as well as comments from members of the public expressing concern about the certainty of the science underpinning the exposure limits.

We did

We have reviewed all submissions and made some amendments, primarily to clarify technical aspects of the Standard. The revised Standard and our responses to individual consultation comments will now undergo formal approvals prior to publication.  

The new Standard will be published on the ARPANSA website in the first quarter of 2021.

We asked

Public consultation on the Delegate’s interim decisions, in relation to scheduling proposals referred to the June 2020 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), was held between 9 September 2020 and 13 October 2020.

You said

We received 41 submissions in response to the consultation. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback we received.

We did

The Delegate considered all submissions in making the final decision on these proposals.

Final decisions regarding oxymetazoline, eletriptan, clotrimazole, sildenafil, ibuprofen and cumyl-pegaclone were published on 25 November 2020.

The final decision for cannabidiol (private application and delegate initiated) was published on 15 December 2020.

We asked

We asked for feedback on our draft Therapeutic Goods Order 106 – Standard for Serialisation and Data Matrix Codes (TGO 106) because we want to make sure the standard is fit for purpose and provides clarity for early adopters of medicine serialisation and data matrix codes on medicines supplied in Australia.

You said

We received 43 submissions in response to the consultation. Respondents provided a range of suggestions to improve the new Order and associated guidance, with many supporting the implementation of a standard to provide consistent regulatory requirements which align with international standards. We appreciate all the feedback we received.

We did

We did

We considered all feedback received and made changes to the standard and guidance. We implemented the updated standard in March 2021. For more information, see new standard for serialisation and data matrix codes on medicines.

Changes we made in consideration of feedback included:

  • Extending the delayed commencement period to allow sufficient time for medicine manufacturers and sponsors already serialising medicines or using data matrix codes to comply with the standard. The standard now commences on 1 January 2023.
  • Reducing requirements to allow sponsors to use data matrix codes to identify medicines without a serial number where serialisation is not required. Medicines that are not serialised will not need to include additional data elements in a data matrix. These changes help to maintain benefits for scanning in health care settings where appropriate technology exists and assist those gradually implementing data matrix codes.
  • Restructuring the standard to streamline and clarify requirements for medicines that are serialised versus medicines that are not serialised but have a data matrix code that contains a GS1 Global Trade Item Number (GTIN).
  • Updating the guidance to clarify requirements for the primary pack and the information that needs to be included in a data matrix code. Primary pack is different to primary packaging, as explained in the guidance and new medicine packaging definitions for sponsors webpage.

We asked

For views and input across all sectors of the Australian community about a Lung Cancer Screening enquiry to investigate the feasibility of a national lung cancer screening program for people at high risk of lung cancer.

 

You said

That many factors should be considered across many sectors of the Australian community and the health system.  Public consultation submissions and input from stakeholders were detailed. Thank you for this feedback.

 

We did

We considered all feedback and engaged a consultant to analyse and summarise consultation outcomes for consideration by the Minister for Health. The Lung Cancer Screening enquiry report will be submitted to the Minister for Health in October 2020.

We asked

Between November 2019 and February 2020, the national obesity strategy Working Group asked for feedback on a proposed framework and ideas to be included in a national obesity strategy.

You said

Across the country, 604 Australians engaged in community events. In addition, 1,038 short-form and 342 long-form surveys were completed, and 35 stand-alone submissions were received. Some further targeted consultation was also progressed with three priority groups (people with disability, young people, older people).

Respondents proposed a range of ideas and suggestions for what could be included in a national obesity strategy, with most highly supportive of a comprehensive strategy. The feedback received is appreciated.

We did

Consultants have reviewed and analysed all the feedback received in the national public consultation and prepared consultation reports, which have been considered by the national obesity strategy Working Group.  Work has also continued on further refining the strategy. 

We asked

For written feedback, based on the Terms of Reference, for the independent review of nursing education - Educating the Nurse of the Future - by 30 June 2019.

You said

We received 83 written submissions and these have now been published (scroll down to view).

We did

Professor Steven Schwartz AM has now submitted the final report to Minister Hunt following completion of the Review. The report will be considered by government and a plan for public release will be developed. There is no fixed date for the release of the report available at this time.

We asked

For feedback on our tobacco control legislation to make sure that it is effective and fit for purpose.

You said

Improvements could be made. Public consultation submissions and input from stakeholder workshops were detailed. Thank you for this feedback.

We did

We considered all feedback and engaged a consultant to analyse and summarise consultation outcomes for Australian Government consideration (scroll down for the consultation summary). This feedback is being used to progress this legislative review.

We asked

In December 2018, we asked for feedback based on the Terms of Reference for the Review of the Quality Use of Medicines Program’s delivery by the National Prescribing Service (NPS MedicineWise).

You said

54 external submissions were received and 26 external interviews were conducted. Submissions were detailed and highlighted the requirement for greater transparency, accountability and efficiency in the delivery of quality use of medicines programs. Thank you for this feedback.

We did

Emeritus Professor Lloyd Sansom AO conducted the Review and a final report has been accepted by Minister Hunt. The public report and the Government’s response to the Review recommendations can be found at

https://www1.health.gov.au/internet/main/publishing.nsf/Content/qum-nps-review

 We are working with NPS MedicineWise to implement the Review’s recommendations.