First supplement firms sought for Australia’s new 'game-changing' health claims
The new claim has been dubbed a 'third-way' option, and sits between the current low-risk listed medicine classification that covers complementary medicines, and the higher level registered medicines for pharmaceuticals.
Speaking at Complementary Medicine Australia’s (CMA) annual conference in Sydney, the Therapeutic Goods Administration's (TGA) Dr Mark McDonald said the package of reforms currently being implemented would "make a big difference to the sector".
To qualify to make the new higher level claims, products must be supported by rigorous scientific evidence, and tested by the TGA for efficacy.
"We will launch the pilot phase in 2018 and there will be full implementation in 2019," said McDonald.
"The design of the claimer is underway and I think internally, we have quite a lot of agreement on this. We'll be looking for expressions of interest from manufacturers by the end of 2017."
The regulatory changes have been broadly welcomed by most industry players. CMA CEO Carl Gibson said the reforms would transform the industry over the next 20 years.
"The changes will award innovation, protect research, and drive the industry forward."
Exclusivity clause
Under the new system, companies that invest in innovation and research will enjoy a two-year period of market exclusivity for newly approved ingredients.
"Achieving an appropriate regulatory regime — one that is supportive of innovation and competitiveness but that doesn't undermine the current high standards for Australian complementary medicines — will assist the complementary medicines industry to bring innovative new products to both the Australian and global markets," said Gibson.
"The use of traditional and complementary medicines is growing worldwide. Consumers have been turning to traditional and complementary medicines as part of a proactive approach to healthcare, becoming more confident in self-selection and willing to take preventive measures to support their health.
"In a supportive business environment, the Australian complementary medicines industry is one industry that has the ability to continue its rapid growth, to support local innovation-rich manufacturing, and Australian-based research and development," he added.
McDonald urged industry to work with the TGA to iron out any creases, but expected that the new rules would "increase predictability for businesses".
