The exposure draft of the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 includes many of the government-agreed recommendations of the Medicines and Medical Devices Review (MMDR).
Trade body Complementary Medicines Australia (CMA) said the bill reiterates the government’s commitment to foster a regulatory environment that is supportive of innovation and competitiveness.
Its CEO Carl Gibson said: “It is encouraging to see that the draft bill includes amendments to provide a new approval pathway for listing complementary medicines with higher therapeutic indications and health claims.
“The goal is to encourage and reward greater investment in research and development by industry, and be an incentive to further expand the clinical research base for complementary medicines, enabling Australian companies to expand business opportunities.”
Current regulations are based on a two-tier system whereby low-risk products are self-assessed by the sponsor and 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.
Efficacy evidence
The draft bill sets out a new listing pathway that will sit between the existing two. These products will be included in the ARTG following certification by the sponsor of 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.”
Gibson said the change would boost product innovation at home and abroad.
“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," he said.
“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."