Australia’s TGA to Take Over Regulation of Therapeutic Goods Advertising

Beginning 1 July 2018, Australia’s Therapeutic Goods Administration (TGA) will be responsible for receiving and considering all complaints about drug and medical device advertisements directed at the public under what it calls "a simplified complaints system."

With the intention of addressing the criticisms of the current system from a public consultation on the regulatory framework for advertising therapeutics in November 2016, the decision means all complaints about the advertising of therapeutic goods to the public will fall under the TGA, as opposed to how the work is currently shared between the Complaints Resolution Panel, multiple industry associations and the TGA.

The new arrangements will be subject to an external review after three years.

"Other aspects of the therapeutic goods advertising framework will also be overhauled to improve compliance with the therapeutic goods advertising legislation," the TGA said, including the removal ofpre-approvals for medicines, which it says "will improve consistency between medicines and medical devices and across advertising media" and "reduce regulatory burden."

TGA