Medicines and medical devices regulation review - consultations

31 October 2016

On 15 September 2016 the Australian Government Response to the Review of Medicines and Medical Devices Regulation was released. It identifies ways to improve access to therapeutic goods for consumers and remove unnecessary red-tape for industry whilst maintaining the safety of therapeutic goods in Australia.

Implementation of consultations

The TGA is seeking comments from interested parties on implementation of the Australian Government response to the Expert Review of Medicines and Medical Devices Regulation.

Consultation forecast

A consultation forecast has been developed to assist stakeholders that are interested in providing input to the TGA on implementing the Australian Government response to the review.

About the review

Terms of reference, panel, reports, discussion papers, questions and answers

Australian Government response to the review

Following consultation with stakeholders including consumers, healthcare professionals and industry, the government has supported the majority of the recommendations of the Review. Find more information in the documents below.

Fact sheets

Prescription medicine regulatory reforms

The reforms will result in new medicines coming to market sooner in Australia, while maintaining a framework for safety, quality and efficacy

Medical device regulatory reforms

The reforms will provide earlier access to new medical devices for consumers and health professionals, and potentially reduce costs for industry

Complementary medicine regulatory reforms

The reforms will support consumer health decisions and improve transparency for industry and consumers

Simplifying regulatory arrangements for advertising of medicines and medical devices

The reforms will simplify the regulation of advertising therapeutic products to the public

Streamlined regulation of patient-specific access to therapeutic products

These reforms will see modifications to the Special Access Scheme (SAS)

TGA advisory committees

Efficiencies will be achieved through reducing the number of statutory advisory committees that provide independent expert advice to the TGA

Further reviews

The Expert Panel Review of Medicines and Medical Devices Regulation recommended that further reviews be undertaken

Questions and answers

Reforms to the medicines regulatory framework

Questions and answers about the medicines regulatory reforms

Reforms to the medical devices regulatory framework

Questions and answers about the medical devices regulatory reforms

Reforms to the complementary medicines regulatory framework

Questions and answers about the complementary medicines regulatory reforms

Reforms to advertising of therapeutic products to the general public

Questions and answers about the advertising regulatory reforms

Reforms to patient-specific access to therapeutic products

Questions and answers about the patient-specific access regulatory reforms