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[e-drug] E-Drug: Review of transparency of Australian Therapeutic Goods Administration (TGA)

Dear E-druggers

Call for input: Review to improve transparency of the Australian Therapeutic
Goods Administration (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.

More information, including the full Terms of Reference and membership of
the Panel are available at:
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:

          o Australian Public Assessment Reports for prescription medicines;
          o Approved Product Information;
          o Consumer Medicine Information;
          o Public summary documents on the ARTG;
          o 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 by the TGA media spokesperson and/or Freedom of
Information requests.

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

To read what a number of individuals and organisations have already provided
to the Panel:

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

The Review Panel will conduct public consultations in late February or early
March 2011, details of which will be provided early next year.


Ken Harvey

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