TGA approvals ‘out of step’: review

The federal government review into the TGA framework for the regulation of medicines and medical devices found Australian requirements “excessive” and “out of step” with international processes.

A discussion paper released by the review committee, spearheaded by former Pharmaceutical Benefits Advisory Committee chairman Lloyd Sansom and supported by former chief medical officer Professor John Horvath and former Medicines Australia chairman Will Delaat, identified a number of areas of unnecessary, duplicative or ineffective regulation that could be removed or streamlined without undermining safety or quality.

The review panel seized the opportunity to examine whether the TGA should be allowed to fast-track certain life-saving medications by introducing an accelerated approvals program similar to the US FDA’s accelerated approval schemes.

Medicines considered under an accelerated program may be granted provisional or