CMA is pleased to announce that the Therapeutic Goods Amendment (2020 Measures no. 2) Bill 2020 was passed in both houses of Parliament without amendment on 18 February 2021. This Bill introduces a 5-year data protection regime for clinical trial information used to support the TGA efficacy-assessed listed medicines, known as 'Assessed Listed' or L(A) complementary medicines. This protection of data, in effect, will:
- prevent generic ‘copy’ AUST L(A) versions of approved medicines from being marketed, thereby ensuring the investment into clinical research reliably generates a commercial return for the sponsoring company.
- incentivise clinical research and public recognition of the efficacy of complementary medicines
- assist to grow the scientific evidence base for complementary medicines
Please read today’s member alert for more information on Data Protection for L(A) complementary medicines, in addition to an update on the progression of funding rounds for the Modern Manufacturing Strategy streams.