The regulator says the reforms aim to increase transparency for consumers, provide additional flexibility for industry and support innovation, while maintaining the safety and quality of therapeutic goods available in Australia.
The consultation includes four key elements:
- The development of a three-tiered risk-based framework for the regulation of complementary medicines. This will introduce a new assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (high risk) pathways.
- The development of a list of permitted indications which must be used by the lowest risk complementary medicines.
- Allowing sponsors to claim that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market assessment by the TGA.
- Mechanisms to incentivise innovation for the complementary medicines sector.
These four points follow a March 2016 Expert Panel review which made 19 recommendations to improve the regulatory controls for complementary medicines manufactured, supplied and/or exported from Australia.
The proposed reforms, are supported by the Government, which said further recommendations from the Review of Medicines and Medical Devices Regulation (MMDR review) will be the subject of further consultation throughout 2017.
According to the TGA, the introduction of the new pathway will bridge the significant gap that exists for industry between the evidence requirements, costs and timeframes for the listed (the self-assessment model) and registered (more stringent TGA efficiency and quality assessment) medicines pathways.
“This will allow greater consumer access to a wider range of evidence-based remedies to self-manage their health,” said the regulator.
Meanwhile, “allowing sponsors to claim that evidence of efficacy has been assessed for products that have undergone pre-market assessment will assist consumers to make more informed healthcare decisions,” they added.
Finally, TGA said the introduction of a list of permitted indications will ensure that complementary medicines that are not subject to pre-market efficacy review are appropriately limited in the claims that can be made.
In its pre-budget submission earlier this year, trade body Complementary Medicines Australia (CMA) welcomed the Government’s continued focus on improving Australia’s competitiveness via removal of burdensome regulatory red tape., including the MMDR reforms.
Carl Gibson, chief executive officer of CMA, said: “Whilst Australia’s complementary medicines industry is proud to be backed by a tough regulatory regime with a world-renowned reputation, the reality is that over-regulation remains one of the biggest risks to the industry.
”The MMDR reforms include the development of a third, modified registration pathway for complementary medicines, with the aim of allowing the ability to make higher level health claims. This will encourage and reward greater investment in research and development by industry, and be an incentive to further expand the clinical research base on complementary medicine products.”
The consultation closes on March 28.