Streamlined approvals means faster access to medicines for patients

Medicines Australia welcomes the commitment of the Australian Government to improve the way medicines are assessed for use in Australia.

The changes should provide patients with more rapid and early access to lifesaving, innovative medicines.

The reforms are a direct response to the Medicines and Medical Devices Review which was tasked with improving and finding alternative ways to rapidly assess the safety and effectiveness of new medicines so that they can be utilised by the Australian healthcare system sooner.

Medicines Australia represents the innovative pharmaceutical industry which researches, develops and manufactures the latest generation in medicines and vaccines.

Medicines Australia is pleased that many of our recommendations have been taken into account in the Australian Government’s response to the Review. The reforms, which will be implemented over the next three years, will ensure that the Therapeutic Goods Administration (TGA) retains and grows its international reputation for ensuring medicines in Australia meet high standards of quality, safety and efficacy.

The reforms include:

  • Increased flexibility in pre-market assessment processes including expedited and provisional approval;
  • A faster process for priority evaluation;
  • Provisions to enable earlier data sets to be considered for provisional evaluation;
  • Increasing use of assessments from comparable overseas regulators (such as the US and EU); and
  • Changes to the regulation of complementary medicines

These new reforms should reduce red-tape and help to lower the costs of bringing a medicine to Australia.

Implementing these changes will reduce or remove the time lag that can occur between Australia receiving new medicines and vaccines compared to other regions like the United States, Europe and the United Kingdom.

Medicines Australia looks forward to working collaboratively with the Government to ensure these reforms are successful.


James Boyce
Phone: 0423 239 265