Time: 16:13

TGA reforms one step closer

Legislation giving effect to government’s response to the review of medicines and medical device regulation is one step closer after last Friday’s public hearing of the Senate Inquiry.

The Community Affairs Legislation Committee spent just four hours questioning stakeholders and senior TGA officials on reforms former health minister Sussan Ley said could accelerate access to medicines by up to two years.

The reforms include a formal system of provisional approval for specified life-saving medicines, changes to the Special Access Scheme to streamline applications and accelerate access, more extensive post-market monitoring of products and better access to information about the effectiveness of complementary medicines.

Most of the questions to representatives of the life sciences sector focussed on its support for the reforms and the related regulatory framework.

TGA head John Skerritt expressed the regulator’s strong support for the reforms.

The reforms were funded with $20.4 million in last year’s Budget and will be progressively rolled out by the TGA over the next two years.

The inquiry is due to report on 27 March.