Australian patients presently have to wait up to 15 months longer to access some breakthrough medicines than patients in the United States or Europe.
Australian patients presently have to wait up to 15 months longer to access some breakthrough medicines than patients in the United States or Europe. psphotograph

Breakthrough medicines to reach Australia sooner

CANCER patients could have access to new medicines two years earlier than at present under changes to the regulation of medicines and medical devices announced by the government this week.

Australian patients presently have to wait up to 15 months longer to access some breakthrough medicines than patients in the United States or Europe.

Delivering the government's response to the Review of Medicines and Medical Devices Regulation, chaired by Emeritus Professor Lloyd Sansom AO, Health Minister Sussan Ley said the government had accepted the majority of the recommendations of the review that would bring significant benefits to consumers, the therapeutic goods industry and health professionals.

"It is a common complaint that certain high profile medicines are not brought to Australia and it is expected that implementing expedited pathways for registration of new medicines will result in many new medicines coming onto the Australian market," Minister Ley said.

He explained that bringing medicines onto the Australian market quicker would be achieved, in part, by greater use of assessment of medicines by comparable overseas regulators like the US FDA and the European Medicines Agency.

"Greater use of assessment of medicines by comparable, trustworthy overseas regulators is estimated to bring medicines from companies that use this assessment pathway to market four and half months earlier than under the current regime," Ms Ley said.

"Provisional approvals will also be available which could result in certain life-saving medicines such as new cancer drugs coming to market two years sooner," Ms Ley said.

She said that other reforms will enable the Therapeutic Goods Administration (TGA) to more efficiently manage 60,000 notifications and approvals annually for patient specific access to unapproved products.

"It will also mean that patients will gain access to essential medicines under the Special Access Scheme faster.

"The reforms will introduce an online system for making and tracking SAS applications. It will also increase the number of medicines subject to streamlined approval through the SAS."

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 regulatory pathways for some medicines in place within 12 months.


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