Avinash Clarke, assistant secretary of the Complementary and Over-The-Counter Medicine at TGA, said the above during a keynote address at the Natural Products Futures Forum organized by the Southern Cross University’s National Centre for Naturopathic Medicine on Oct 23.
Clarke was giving a presentation titled “Australian Regulation of Complementary Medicines: An update from the TGA”.
There are currently 778 permissible indications under the listed medicines framework, which could be further increased.
Health supplements are regulated as listed medicines, assessed listed medicines, or registered medicines in Australia.
Listed medicines do not have to undergo premarket evaluation and can only use permitted ingredients and permitted indications, and they must hold evidence at the time of listing to support its indications. In contrast, assessed listed medicines have to undergo premarket evaluation for efficacy, and can use at least one intermediate level indication on top of permitted indications.
“We want to focus on getting out clear guidance, for example, what a delegate looks at when assessing applications for new permitted indications,” he said during his speech.
This could be in the form of a webinar and part of an ongoing conversation with the industry.
“It is also part of ongoing conversations around how we can support permitted indications where appropriate. For listed medicines, they cannot be too strong in indications, such as curing a serious disease,” he said.
What are permitted indications?
Permitted indications can focus on health maintenance, health enhancement, prevention of a dietary deficiency, and a non-serious form of a disease, ailment, defect or injury.
Examples include maintain intestinal good flora, enhance healthy digestion, and relieve digestive discomfort.
At the moment, the TGA does not evaluate evidence to support the use of a new proposed indication for a listed medicine at the time of application, and in general, there is no requirement to submit supporting information.
However, the TGA will assess whether the indication meets the criteria for permitted indications and the permitted indication assessment tool was already developed to help applicants determine if a proposed indication is suitable to be included in the permitted indication list.
Vitamin B6, labelling rules
The ongoing plans in reducing the Recommended Daily Dose (RDD) of vitamin B6 sold in retail to 50mg in response to increased reports of peripheral neuropathy, will also see a decision finalized possibly in next month.
The are also plans around the remaking of therapeutic labelling rules, including TGO 91 and TGO 92 which are standard for labels of prescription and related medicines, and standards for labels of non-prescription medicines respectively.
Complementary medicines would need to comply with TGO 92.
“The other thing that will keep us busy is the remaking of a couple of therapeutic labelling rules, TGO 91 and TGO 92. This will be quite a comprehensive consultation on a range of topics, and we are hoping to get that out by the end of the year…That’s a priority for us,” said Clarke.
