TGA issues updated international alignment strategy

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The TGA has issued its international engagement strategy for the years 2021 to 2025, emphasising increasing collaboration with comparable regulators in other countries.

It says the TGA will "continue to make sovereign decisions" but that it will increasingly collaborate with other regulators to expedite and inform decisions on the approval of therapeutic interventions important to Australian patients.

It says this collaboration has been on show during the COVID-19 pandemic and that it has "streamlined the authorisation process for certain therapeutics, vaccines and medical technologies to support these efforts."

The strategy recognises Australia's comparatively small market size compared to the US and Europe. It says that while this means new products will often be made available in these markets first, it also highlights the importance of international collaboration.

It says this collaboration will also be important given the impact of rapidly emerging new technologies such as artificial intelligence (AI), software and digital platforms, particularly for medical devices.

"Our regulations, whilst flexible to support emerging trends, need to safeguard patient harms in relation to accessibility, cybersecurity, interoperability, data integrity and security. Ensuring the safety, quality and performance of the increasing demand for personalised implants requires a balance between necessary regulatory oversight, without impeding innovation," it says.

It continues, "The increasing complexity and technological sophistication of biological products, including cell and gene-based therapies, vaccines and regenerative medicine therapies also require innovative approaches to regulate. Novel technologies for advanced manufacturing of these products will also require advances in the TGA's scientific capabilities to inform regulatory oversight."

The new plan includes four strategic priorities - global policy alignment, pre-market global collaboration, post-market global monitoring and regional regulatory capabilities.

Two of the highlighted projects are the continued international collaboration on the evaluation of COVID-19 vaccines and therapeutics and oncology submissions through Project Orbis.