Therapeutic Goods Administration (TGA) Australia has published a document regarding its business plan and the priorities for 2021 and 2022.
The business plan contains detailed information on the priorities, which are product regulation and safety, regulatory reform, international engagement, and regulatory education and compliance.
TGA plans to focus on the prioritisation of medicines and medical devices associated with COVID-19, the regulation of other medicines and medical devices, development of regulatory scientists, modernisation of TGA’s system with digital transformation, as well as the focus on the transition to new facilities. These are linked to product regulation and safety.
As for the regulatory reform aspect, TGA is focusing on the support for emerging medical technologies and is aiming to create an efficient and simple system for products to be evaluated and to reach the market safely. The implementation of a program of Good Clinical Practice Inspections of local clinical trials, and completion of business processes to proceed with conformity assessment for medical devices are some of the initiatives planned by TGA.
The section on international engagement highlights four strategic priorities for TGA namely, building a globally aligned regulatory framework, increasing collaboration to reduce regulatory burden, engaging with other international networks to smoothen the process of post-market global surveillance, and to fortify the regulatory abilities regionally.
TGA has also listed regulatory education and compliance as one of the priorities, where the importance of the monitoring of therapeutic goods has been highlighted in the plan.
More details can be found in “TGA Business Plan 2021-22, V1.0, August 2021”: https://www.tga.gov.au/sites/default/files/tga-business-plan-2021-22.pdf