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Call for input: Review to improve transparency of the Therapeutic Goods Administration (TGA)


11 February 2011

This consultation opened on 22 December 2010 and closed on 11 February 2011.

Call for input

The purpose of this paper is to provide you with early information on the opportunity to contribute to the transparency Review of the TGA.

On 16 November 2010, the Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, announced a comprehensive review of the way the TGA communicates its regulatory processes and decisions. This is consistent with the resolve of the Gillard Government to ensure that the Australian public is better informed about the benefits and risks of therapeutic goods, including all medicines and devices, and to address community concerns that have been raised about the lack of information made available by the TGA.

The Review Panel is being chaired by Professor Dennis Pearce AO, who has conducted numerous reviews for both the Commonwealth and ACT Governments. Professor Pearce is working with consumer, health professional and therapeutic goods industry representatives. The Panel is due to report by end of April 2011.

Therapeutic goods include:

  • prescription and over-the-counter medicines (such as pain relievers and cough and cold preparations);
  • complementary medicines (including vitamin and mineral supplements, and herbal medicines); as well as
  • medical devices (including blood pressure measuring devices, orthopaedic joint replacements, heart valves and diagnostic imaging equipment, such as CT scanners).

The Parliamentary Secretary has asked the Panel to report on:

  • opportunities to provide more information about products on the market;
  • how the public can improve its understanding of the ways new products are assessed and products on the market are monitored;
  • the timing for making information available about new products;
  • the type of information and how it is made public by comparable overseas regulators;
  • constraints (or barriers) to the release of further information, such as implications for public health and safety; and
  • how the material can be published - e.g. use of the internet and other publication methods.

For the full Terms of Reference and membership of the Panel go to Transparency review of the TGA.

In early 2011, the Panel have arranged to advertise the opportunity to make submissions.

Submissions were to be received by the Secretariat no later than Friday 11 February 2011.

The Panel would like to hear from the general public:

  • about instances where it could have been useful for you to have had access to better information about your medicine, supplement or device;
  • what type of information could have helped you?
  • the way you would like to access that information - e.g. on the internet or other electronic media; through your doctor, pharmacist or health professional; in a brochure or handout about a specific medicine or a therapeutic device;
  • whether you have ever looked for information provided by the TGA and, if so, where did you find it and was it helpful?
  • what other information you use?

If you are a health professional the Panel would like your comments on:

  • information provided by the TGA on the safety, quality and efficacy of medicines and medical devices included on the Australian Register of Therapeutic Goods (ARTG) including:
    • Australian Public Assessment Reports for prescription medicines;
    • Approved Product Information;
    • Consumer Medicine Information;
    • Public summary documents on the ARTG;
    • TGA Advisories and Medicines Safety Updates;
  • any problems that you have encountered in regard to the transparency of TGA processes and decision making.

If you participate in production or marketing of therapeutic goods, please consider providing comment on:

  • what ways you think the TGA could provide greater assistance to you in the evaluation and registration, listing or marketing processes; and
  • any issues that you have encountered in regard to the transparency of TGA processes and decision making.

If you work in the media:

  • comments would be appreciated on the timeliness, quality and utility of information provided in response to inquiries and/or Freedom of Information requests.

Everyone is invited to comment on any other matters relevant to the terms of Reference.

To read what a number of individuals and organisations have already provided to the Panel see Transparency review of the TGA.

Please note that any comment or submissions you provide will be made available to the public.