What’s trending in medicines regulation?

Last month, Adj Prof John Skerritt, Deputy Secretary at the Therapeutic Goods Administration (TGA) in Australia delivered a most interesting presentation at the ARCS Seminar: Regulatory and Market Access Developments in Europe and US. His presentation provided a local viewpoint on recent changes in the medical technology and the pharmaceutical landscape, and considered the future role of the TGA in a global context.

Looking back at 2016, Prof Skerritt noted that 39 NCE approvals were granted by the TGA versus 22 NCE approvals from the US Food and Drugs Administration (FDA). This picture contrasted significantly with the previous year when 27 and 45 NCE approvals were granted by TGA and FDA respectively.

Considering initiatives to speed early access to important new medicines, Prof Skerritt told his audience that new pathways are coming at TGA in the shape of priority review and provisional approval/adaptive licensing. The TGA’s aim is to introduce the former initiative later this year and provisional approval/adaptive licensing procedures in 2018.

To view the presentation or to download it in pdf format, please click here.