Australia mulls over international market approval process
Some medicines could be fast-tracked for approval if they have already been approved by trusted authorities in other countries
Australia’s government is considering proposals developed by a panel appointed by its health ministry that could see market approvals for some medicines ‘fast tracked’ by the Australian Therapeutic Goods Administration (TGA) if they have already been approved by trusted authorities in other countries. The suggestion has come via a comprehensive review of the country’s market approval procedures for pharmaceuticals.
Stage one of the review, conducted by an expert panel of three independent experts – Emeritus Professor Lloyd Sansom, former Medicines Australia Chairman Will Delaat and Professor John Horvath – was released in June by Australia’s department of health.
Following submissions from various stakeholders, the 183-page report made 32 recommendations to improve medicines regulation in Australia, including a three-track process for approval, identifying comparable overseas regulators using transparent criteria and enhancing post-market monitoring.
Medicines Australia CEO Tim James welcomed the first report. 'Encouraging worksharing with overseas regulators, accelerated approval pathways and retaining the capacity of the TGA to undertake assessments of therapeutic goods are sensible proposals and it’s good to see that this independent report agrees,' he said in June.
The second stage of the review, addressing the regulation of complementary medicines and the advertising framework for therapeutic goods, is currently under consideration by the government and results could be published by the end of the year. Follow up legislative proposals would then follow.
Australia's Health Minister Sussan Ley welcomed the report for making recommendations 'to improve, and reduce red tape in, the regulatory frameworks for prescription medicines and medical devices' and helping to ensure that 'Australians can access the latest treatments in a timely manner without compromising safety and quality'.
