Stakeholders welcome regulatory framework report


lots of colourful different medicines

The Australian Self Medication Industry and Complementary Medicines Australia have welcomed the Stage Two Expert Panel report on the regulatory framework for medicines and medical devices.

ASMI supports the majority of the Expert Panel’s recommendations on the regulation of complementary medicines and therapeutic goods advertising,” says ASMI CEO, Deon Schoombie.

“We are pleased the Panel recommended a risk-based approach to regulation and accepted many of the proposals industry put forward in its submissions to address the acknowledged shortcomings in the current system.

“We look forward to participating in the development of reforms coming out of these recommendations.

“We reserve judgement about the Panel’s recommendations on complaints handling and pre-vetting of advertisements as these two areas are highly complex, involve several inter-connected systems and will require a suite of additional reforms.

“We will consult broadly with stakeholders about these recommended reforms to ensure the most effective systems are implemented.

“We disagree with the Panel’s recommendation to retain restrictions on the advertising of Schedule 3 medicines and will continue our advocacy for S3 advertising reforms,” he says.

Carl Gibson, CEO of CMA also acknowledged the report.

“This is a once in a generation opportunity to shape the regulatory framework for the future in line with the Government’s Industry, Innovation and Competitiveness Agenda – and to find the required balance between a regulatory environment that protects consumers without unduly restricting the ability for Australian businesses to compete in an increasingly globalized environment,” he says.

“CMA supports the Government’s stated focus of better aligning regulatory protections with risks and to ease the regulatory requirements where they do little to improve consumer protections and are a barrier to business and innovation.

“Australian complementary medicines are manufactured and regulated to the highest standards. The aim of the Review is to identify areas of unnecessary or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods, taking into account how Australia can continue to be positioned to respond effectively to global trends.

“The complementary medicines industry looks forward to engaging further with the regulator and government to collaboratively work towards an appropriate and ‘light-touch’ regulatory framework for complementary medicines,” says Gibson.

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