The rules, included in the Medicines and Medical Devices Review (MMDR), contain amendments to provide a new approval pathway for listing complementary medicines with higher therapeutic indications and health claims.
Carl Gibson, CEO of industry trade body Complementary Medicines Australia, said: “CMA welcomes the passing in the Senate of the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and reiterates its support of the government’s commitment to foster a regulatory environment that is supportive of innovation and competitiveness.”
The new health claim sits between the current, low-risk listed classification for complementary medicines, and the higher level classification for pharmaceuticals.
To qualify to make the new higher level claims, products must be supported by rigorous scientific evidence, and tested by regulator the Therapeutic Goods Administration (TGA) for efficacy.
Under the new system, companies that invest in innovation and research will also enjoy a two-year period of market exclusivity for newly approved ingredients.
Gibson added: “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.
“Achieving an appropriate regulatory regime – one that is supportive of innovation 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.”
The recently published 2017 Complementary Medicines Industry Audit showed that the Australian industry had grown to revenues of $4.7bn as a result of increased demand from consumers in both the domestic and international markets.
After the USA, Australia is the second largest exporter of complementary medicines.
The high international demand for Australian products is driving a major expansion of local manufacturing, with an anticipated annual growth rate of 3.9%.
Gibson said: “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 and regulatory 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.”