THE Therapeutic Goods Administration (TGA) has outlined how it will interact with overseas organisations going forward, with a new International Engagement Strategy 2016-2020 articulating the agency's "key international business priorities".
The document details ways in which the TGA will act in line with the government's Response to the Expert Panel Review of Medicines and Medical Devices Regulation, which accepted a range of recommendations aiming to speed up approval of new medicines based on overseas trials.
The TGA reform agenda includes increasing the use of overseas assessments by comparable regulators, increasing flexibility in pre-market assessment processes including expedited evaluations and provisional approvals, and "taking a more risk-based approach to variations to medicines and medical devices and access to products not listed on the Australian Register of Therapeutic Goods".
Under the policy the TGA will continue to support the Medical Device Single Audit Program, as well as develop a more comprehensive post-marketing monitoring scheme including enhanced collaboration and the exchange of information with overseas regulators.
The agency will "provide access for Australian consumers to certain medicines and medical devices that have had evaluations either conducted in part or comprehensively by comparable overseas regulators," with the aim of reducing duplication, while still maintaining oversight by the TGA as the "final decision-making authority" - see www.tga.gov.au.
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