TGA reveals new regulatory science strategy 2020-2025

New technologies such as gene therapies, other cell and tissue therapies, 3D-printing, and software as a medical device are transforming the way Australians manage their health, and how medical conditions are treated and prevented.

At the same time, the design of clinical trials has changed and new approaches are being applied for gathering and utilising real world evidence. This is the case both for these “new technologies” and for renewed interest in therapies such as those based on medicinal cannabis.

Adjunct Prof John Skerritt, Deputy Secretary for Health Products Regulation Group (HPRG) Department of Health said “It is important that our regulatory scientists remain up to date with the latest health product technologies to ensure that Australians are accessing safe and effective therapeutic products.”

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“I am therefore pleased to share the first HPRG Regulatory Science Strategy which outlines how HPRG will maintain and build its regulatory science capability over the next five years, as we continue to work towards better health outcomes for all Australians,” he concluded.

This document outlines a strategy for how HPRG, which comprises the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC), will maintain and build regulatory science capability over the next five years. This will help meet their vision of better health and wellbeing for all Australians through regulatory excellence.

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The strategy is focussed on four key areas:

• Maintain and build skills in regulatory science
• Improve domestic and international collaboration with other government agencies, scientific organisations and regulators
• Increase responsiveness to emerging technologies
• Improve communication and engagement with stakeholders about regulatory science.

Initiatives to address each of the four key areas are proposed in this document, along with preliminary ways to implement them. These initiatives, which will be implemented in a stepwise approach over the next five years, will contribute to the quality of HPRG’s work and will help build regulatory science capabilities at HPRG.