Australia Unveils Strategy for Engaging With Foreign Regulators
Australia’s Therapeutic Goods Administration (TGA) revealed a three-part plan on Monday to operationalize its strategy on engaging international regulators through FY 2019.TGA said the new plan “identifies projects and activities, the benefits to be realized from those activities, and the line areas responsible for delivering on the three goals for international engagement:” Contribute to public health and safety through regulation, work with others to improve the regulatory system and participate in information sharing and convergence activities.
The projects—some of which are already underway—are intended to build off of the goals TGA set in its 2016-2020 international engagement strategy throughout the next fiscal year.
Retained projects include TGA’s continued work in collaboration with the International Coalition of Medical Regulatory Agencies to create a global framework on information-sharing. On the device side, the plan involves engaging the Global Medical Device Nomenclature Agency in a project for exchanging information to develop a global approach on regulatory terminologies.
The regulatory authority also intends to continue participating in the European Directorate for the Quality of Medicines, the Australia, Canada, Singapore, Switzerland Consortium, and the International Medical Device Regulators Forum (IMDRF).
Through IMDRF working groups, TGA plans to update the list of international standards recognized by the 10 participating regulatory authorities. It will also develop new guidance on personalized devices and advance the IMDRF “Table of Contents” structure. Consultations on these IMDRF work items and others were opened after the last management committee meeting. The next meeting is set to take place from 18 to 20 September in Beijing, China. In addition, TGA will support assessments obtained via IMDRF’s Medical Device Single Audit Program that “are to be performed in the Western Pacific Region” throughout FY 2019.
TGA’s plan also involves developing an electronic common technical document and a biopharmaceutics classification system via its participation in the International Conference on Harmonization and engaging its counterparts on a regular basis to identify medicine shortages.
Other projects relate to promoting the use of comparable overseas regulators for a work-sharing approach to pharmaceutical and medical device applications through newly established policies.