The TGA has released its Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 draft for consultation
Submissions regarding the bill will be open until 9am on 5 September 2017.
The draft includes a new pathway for listed medicines.
Complementary Medicines Australia has welcomed the exposure draft and says it reiterates its support of the Government’s commitment to foster a regulatory environment that is supportive of innovation and competitiveness.
“It is encouraging to see that the draft Bill includes the balance of government agreed recommendations of the Medicines and Medical Devices Review (MMDR), including amendments to provide a new approval pathway for listing complementary medicines with higher therapeutic indications and health claims,” says the CMA’s CEO, Carl Gibson.
“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 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.”
“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.”
“The recent Australian complementary medicine industry audit shows that the industry is growing rapidly due to increasing demand from consumers, both in Australia and internationally.”
This growth is backed by a global reputation for quality and safety, and supported by a robust regulatory system, he says.
“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,” said Mr Gibson.
The draft can be accessed here.