Expert Review of Medicines and Medical Devices Regulation

Page last updated: 15 September 2016

The Review

The independent review of medicines and medical devices regulation was announced on 24 October 2014. The Review examined Australia's medicines and medical devices regulatory framework and processes with a view to identifying:
  • areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and
  • opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
The scope of the Review is set out in its Terms of Reference:

Word version: Review of Medicines and Medical Devices -Terms of Reference (Word 18 KB)
PDF version: Review of Medicines and Medical Devices -Terms of Reference (PDF 70 KB)

About the Expert Panel

The Review of Medicines and Medical Devices Regulation was undertaken by a panel of three eminent experts:
  • Emeritus Professor Lloyd Sansom AO (chair) is a distinguished educator, researcher and policy adviser who has sat on numerous government and industry advisory groups. Professor Sansom played a major role in the development of Australia’s National Medicines Policy and was Chair of the Pharmaceutical Benefits Advisory Committee between 2001 and 2012.
  • Mr Will Delaat AM has over 40 years’ experience in the pharmaceuticals industry in a range of roles. He was Managing Director of Merck, Sharp & Dohme (Australia/NZ) for 11 years to 2008 and the Independent Chairman of Medicines Australia until December 2011. Mr Delaat is currently on the Boards of a number of pharmaceutical companies including Pharmaxis Pty Ltd and EnGenelC Ltd.
  • Professor John Horvath AO was the Chief Medical Officer from 2003 to 2009. He continues to advise the Department of Health as principal medical consultant and is on numerous health-related Boards and Committees, including the Prosthesis List Advisory Committee, which he chairs.
The Panel reported in two stages. The first report, on the regulatory frameworks for medicines and medical devices, was provided to Government on 31 March 2015.

The Panel’s second report, addressing the regulatory frameworks for complementary medicines and the advertising of therapeutic goods, was delivered to the Health Minister on 31 July 2015.

Stage One Report on the Regulatory Framework for Medicines and Medical Devices

On 31 March 2015, the independent Expert Panel provided the Government with its first report on the review of medicines and medical devices regulation. The Panel made 32 recommendations. In summary, the first report recommends:
  • expanding the pathways by which sponsors can seek marketing approval for a medicine or medical device, including making provision for utilisation of assessments conducted by comparable overseas regulators, and for expedited assessments in defined circumstances;
  • identifying comparable overseas regulators using transparent criteria;
  • enhancing post-market monitoring of medicines and medical devices and streamlining post-market requirements for products in the Australian Register of Therapeutic Goods; and
  • improving transparency and predictability of processes and decisions, to ensure Australians have timely access to high quality, safe and efficacious products.
Word version: Review of Medicines and Medical Devices Regulation Stage One Report (Word 1603 KB large file)
PDF version: Review of Medicines and Medical Devices Regulation Stage One Report (PDF 3059 KB large file)

Stage Two Report on the Regulatory Frameworks for Complementary Medicines and Advertising of Therapeutic Goods

On 31 July 2015, the second (and final) report of the Expert Panel was provided to Government, making a further 26 recommendations. In summary, the second report recommends:
  • expanding the pathways by which sponsors can approve an ingredient for use in a listed medicine, and for marketing approval of a listed complementary medicine;
  • enhancing the transparency and predictability of processes and evidence requirements associated with ingredient approvals and complementary medicine marketing approvals;
  • improving and clarifying the interface and synergies between the market approval of therapeutic goods and advertising requirements that ensure consumer protections are balanced with the availability of information for consumers and health professionals to make informed spending and health decisions; and
  • enhancing and streamlining the advertising framework to facilitate and maximise compliance and the management of complaints.
Word version: Review of Medicines and Medical Devices Regulation Stage Two Report (Word 367 KB)
PDF version: Review of Medicines and Medical Devices Regulation Stage Two Report (PDF 1391 KB large file)

Review Recommendations

Word version: Review of Medicines and Medical Devices Regulation - Recommendations (Word 112 KB)
PDF version: Review of Medicines and Medical Devices Regulation - Recommendations (PDF 644 KB)

Frequently Asked Questions about the Review of Medicines and Medical Devices Regulation Reports have been developed for information.

Should you have any queries in relation to the report please contact the TGA mailbox: info@tga.gov.au.

Stage One Discussion Paper

On 21 November 2014, the Panel called for submissions from interested parties, in response to its Stage One Discussion Paper on Medicines and Medical Devices Regulation. Submissions to Stage One of the Review closed on 5 January 2015.

Word version: Discussion Paper on the regulation of medicines and medical devices (Word 301 KB)
PDF version: Discussion Paper on the regulation of medicines and medical devices (PDF 1338 KB large file)

Stage Two Discussion Paper

On 20 February 2015, the Panel called for submissions from interested parties, in response to the Panel's Discussion Paper on Complementary Medicines (Chapter Nine). Submissions to Stage Two of the Review closed on 8 April 2015.

Word version: Complementary Medicines Chapter Nine (Word 158 KB)
PDF version: Complementary Medicines Chapter Nine (PDF 498 KB)

Government Response to the Review of Medicines and Medical Devices Regulation

Following extensive consultation with stakeholders including consumers, healthcare professionals and industry, the Government, for the most part, supports the recommendations of the Review of Medicines and Medical Devices Regulation.

See The Government Response to the Review of Medicines and Medical Devices Regulation.

Review of Medicines and Medical Devices Regulation - Frequently Asked Questions

Who can answer questions about the Review reports?

The Department is happy to receive, and provide a response to, questions. Please direct any questions to the Therapeutic Goods Administration (TGA) mailbox.

Will there be an opportunity to provide feedback on the reports?

The Minister for Health and the Minister for Rural Health have indicated that the Government will consult with key stakeholders. Following the release of the Stage One report, stakeholders have been consulted on a range of issues relating to the recommendations for medicines and medical devices and unapproved products.

Following the release of the Stage Two report, the Government has consulted with stakeholders on recommendations relating to the regulation of complementary medicines and the regulation of advertising of therapeutic goods.

In addition, the Department is happy to receive feedback from the general public and other interested stakeholders. Please direct your comments to the TGA mailbox.

Where can I get a copy of the reports?

The first stage report and second stage report are available on the Department of Health website.

A consolidated set of recommendations are available on the Department of Health website for ease of reference, noting that the recommendations do not stand alone, and should be considered in the context of the reports.

The Australian Government response to the Review can also be found on the Department of Health website.

What was the purpose of the Review?

The Review was announced by the then Minister for Health, the Hon Peter Dutton MP and the then Assistant Minister for Health, Senator Fiona Nash in October 2014 to examine the medicines and medical devices regulatory framework and processes with a view to identifying:
  • areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of medicines and medical devices available in Australia; and
  • opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of medicines and medical devices.
The Review does not make recommendations regarding any aspect of the Pharmaceutical Benefits Scheme or other reimbursement schemes.

When was the first report provided to the Government?

The first report was provided to the Health Ministers on 31 March 2015. This report addresses the regulation of medicines and medical devices. The first report is available on the Department of Health website.

When was the second report provided to the Government?

The second (and final) report was provided to the Health Ministers on 31 July 2015. This report addresses the regulation of complementary medicines and the regulatory framework for the advertising of therapeutic goods. The second report is available on the Department of Health website.

Why do the reports mention a National Regulatory Authority?

The authority responsible for regulating therapeutic goods in Australia is the Therapeutic Goods Administration (TGA), which is part of the Australian Government Department of Health. Throughout the reports, when discussing past actions of the authority, the Panel has referred to the TGA. However, to be consistent with the words used by the World Health Organization, when referring to the Australian regulatory authority in general terms or in future tense, the Panel has used the term ‘National Regulatory Authority’ (NRA).

Does this mean the Therapeutic Goods Administration will cease to exist?

That is not the Panel's recommendation. The Panel has chosen to use a generic term to describe our regulatory authority. Further, the reports recommend that Australia continues to have the sovereign right to decide which therapeutic goods are approved and made available to Australians.

Will the Review result in medicines, devices and complementary medicines being made available to the consumer much more quickly than in the past?

The reports make recommendations about increasing the pathways for marketing approval, including pathways for expedited approval.

Will the Review result in medicines, devices and complementary medicines being more accessible and affordable in Australia?

The reports make recommendations about the marketing approval of therapeutic products that could have flow on effects on market availability and costs. However, the reports do not make any recommendations about subsidy programs that also influence the access and affordability of some products.

Did the Review deliver red tape reductions for the regulation of therapeutic products without compromising on public health and safety?

The reports make some recommendations to reduce regulatory burden for industry, and other recommendations to enhance the regulatory framework and processes, all with the aim of ensuring public health and safety.

Does the Government agree with all the recommendations of the Panel?

Following consultations with key stakeholders and considering any comments from the general public, and other interested stakeholders, the Government will has considered the recommendations of the Panel.

The reports will behave been considered in the context of the findings of other relevant reviews and reform work being undertaken in the portfolio.

When will the Review recommendations be implemented?

The reforms will be progressively rolled out by the TGA over the next 18 to 24 months, with new regulatory pathways for some medicines in place within 12 months.