Current regulations are based on a two-tier system whereby low risk products are self-assessed by the sponsor and are listed on the Australian Register of Therapeutic goods (ARTG) without pre-market assessment.
Meanwhile, higher risk medicines are registered on the ARTG following pre-market assessment of product quality, safety and efficacy.
The TGA is proposing a new listing pathway that will sit between the existing two. These products will be included in the ARTG following certification by the sponsor about the safety and quality of the product, and TGA assessment of the efficacy evidence supporting the proposed indications.
According to the regulator: “The three-tiered approach bridges the significant gap that exists for industry between the evidence requirements, costs and timeframes for the existing listed and registered medicines.
“There will be clear risk-based eligibility criteria for industry and consumers to differentiate between pathways.”
The plans were recently put out to consultation, with the TGA reporting that submissions showed broad stakeholder support for the reforms.
“However, some modifications were proposed, particularly in relation to the evidence requirements and protection of efficacy data for products assessed through the new listing pathway. We will continue to review implementation options to address these concerns,” it added.
Under the current process, TGA says the system does not protect the resources invested by innovators who research and develop new ingredients for use in supplements.
The new roles propose a two-year period of market exclusivity for newly-approved ingredients under the third pathway, to “encourage research into emerging areas of complementary medicines.”
Trade association Complementary Medicines Australia has previously signalled its support for the proposals.
“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,” said CMA CEO Carl Gibson.
“Encouraging and supporting business expenditure on research and development in complementary medicines will help Australia to capture the growing market for these goods, nationally and internationally, as well as provide significant economic and health benefits for our nation.”
Earlier this week reported that the TGA was to assume sole responsibility for overseeing complaints made about supplements advertising from July 2018.