Reform of Regulation of Medicines and Medical Devices

The Australian Government today released its response to the Review of Medicines and Medical Devices Regulation, (opens in a new window) known as the Samson Review.

Chaired by Emeritus Professor Lloyd Sansom AO, the independent expert review 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.

Following consultation with stakeholders including consumers, healthcare professionals and industry, the government has deferred just two of the 58 recommendations of the Review, namely the:

  • establishment of registries for all high-risk medical devices (recommendation 22);
  • review of the Therapeutic Goods Administration's (TGA) funding arrangements (recommendation 32).

Health Minister Sussan Ley said accepting the majority of the recommendations will bring significant benefits to consumers, the therapeutic goods industry and health professionals.

"Bringing medicines onto the Australian market quicker will be achieved, in part, by greater use of assessment of medicines by comparable overseas regulators like the US FDA and the European Medicines Agency," Minister Ley said.

Ms Ley said other reforms will enable the TGA to more efficiently manage 60,000 notifications and approvals annually for patient specific access to unapproved products.

"Consumers will also benefit from more extensive post-market monitoring of products and better access to information about the effectiveness of complementary medicines.

"Under the reforms sponsors will be encouraged to publish on their website the evidence that it holds to support all indications included on the product as well as information that will assist consumers to compare complementary medicines.

"Advertising for therapeutic products will be simplified but there will be stricter penalties for non-compliance."

Minister Ley said the reforms strike the right balance between consumer protection and reducing red tape for companies importing or manufacturing new medicines, medical devices or complementary medicines.

Minister Ley said she was confident these reforms will allow Australian consumers to be confident about the safety, quality, and performance of therapeutic products available to them through Australian pharmacies, supermarkets and in hospital procedures.

The government allocated $20.4 million in the last federal budget to implement the reform measures to improve the regulation of therapeutic goods in Australia.

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

>> For more information visit the TGA (opens in a new window) or Department of Health (opens in a new window) website.

>> Visit the TGA website for more information about complementary medicines (opens in a new window) and medical devices (opens in a new window) reforms.