Amid a tense week for CMs in Australia, the TGA has called for contributions on reforms to their regulatory framework
The Sansom Review made 19 recommendations to improve the regulatory framework for complementary medicines manufactured, supplied and/or exported from Australia.
Recommendation 39, that there should be three pathways by which sponsors can seek entry on the ARTG for complementary medicines, was agreed to by the Government when it responded to the Review’s recommendations.
“The Panel recommended that these pathways be established on the basis of a hierarchy of evidence as a graded response to the risk profile of complementary medicines and the associated indications that can be made,” says the TGA.
“The establishment of three assessment pathways for complementary medicines also impacts on other decisions of government, including:
- the establishment of a list of permitted indications (Recommendation 38);
- the publication of a claim that the medicine has been assessed by the TGA for efficacy (Recommendation 45); and
- introduction of mechanisms to improve the competitiveness of the Australian complementary medicines industry (Recommendation 50).”
“The review’s recommendations relating to complementary medicines arose from the observation that Australia’s regulatory framework for these products does not appropriately align regulatory protections with risks,” says the TGA.
The three pathways will include:
- “Medicines will continue to be included on the ARTG following self-assessment and certification by the sponsor of the safety, quality and efficacy of the product. This is essentially the current listing pathway except that we will provide a list of permitted indications for sponsors to enter their product indications on the ARTG. We will also be increasing our post-market compliance monitoring for these products.”
- “Medicines could be included on the ARTG following sponsor self-assessment and certification of the safety and quality of the product, coupled with TGA assessment of the efficacy evidence supporting the proposed indications. This new pathway will allow sponsors to apply for indications that fall outside the permitted indications list but in all other respects the medicines meet the current eligibility criteria for listed medicines (e.g. contain only permitted ingredients).”
- “Medicines will continue to be included in the ARTG after a full assessment of the safety, quality and efficacy of the product by the TGA. This retains the current registration pathway and is commensurate with the higher level indications made or ingredients used in these products.”
The consultation period, which runs until Tuesday, 28 March 2017, is hoped to provide an opportunity for consumers, health professionals and sponsors to contribute to the reforms.
The reform of the CM regulatory framework was discussed on last night’s episode of Four Corners, Swallowing It, which was critical of pharmacy for stocking CMs with little or no good evidence to support their use.
“We would test the efficacy, and the company would be able to say this product has been TGA tested, and has passed,” said Adjunct Professor John Skerritt, head of the TGA.
“They will carry some form of indication that they’ve been tested for safety and efficacy, whether it’s a sticker, whether it’s words, is still there to be discussed both with stakeholders and Government.
“And we expect that by about April we’ll be able to go to the Minister and other ministers, and say, ‘These are the options we’ve put in front of stakeholders… whether it’s a tick, whether it’s a symbol, or whether it’s some wording about the product having been tested.”
A submission form is available here.