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News & Trends - Biotechnology

Parliamentary report paves the way in securing faster review for cell therapies

Health Industry Hub | March 9, 2022 |
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Biotech News: The Therapeutic Goods Administration (TGA) is holding a consultation into the feasibility, potential eligibility criteria and determination process for a proposed priority review pathway for biologicals including human cell and tissue therapies.

Medicines Australia and AusBiotech used the recent House of Reps parliamentary inquiry to raised the importance of a priority review and provisional registration pathway for biologicals. They called for changes to TGA’s approach, leading the parliamentary report to indicate that the current pathways is inadequate.

The TGA has responded by proposing the creation of a pathway to accelerate the assessment of treatments for life-threatening diseases or seriously debilitating conditions. The agency has worked in the past to facilitate early access to some products but lacks a dedicated pathway.

The TGA plans to establish a legislated timeframe of 150 working days for priority review, consistent with benchmarks set in the US and EU, and Australia’s existing pathway for prescription medicines.

TGA expects applicants to submit “robust evidence from summaries of full study reports” to show there is a high probability that a biological will provide patients with a clinically relevant benefit.

The agency is seeking to understand whether people and organisations impacted by the proposal support the creation of a priority review pathway for biologicals and what ramifications they foresee the change having. The agency is also seeking feedback on whether it should change the eligibility criteria.

If a priority review pathway is implemented, TGA also will establish a determination pathway for deciding if a biological is eligible. TGA plans to hold optional pre-submission meetings three to six months before the applicant files for registration. Applicants that skip the meeting step can notify TGA of their intent to lodge a determination application. TGA recommends companies file the determination application itself three months before submitting for registration. The agency aims to decide on determination applications within 20 working days.

If priority review status is granted, the agency is proposing that an applicant be given six months to provide the full submission. The agency plans to publish the outcomes of approved applications for priority review determination of biologicals but wants to gather feedback on the plan first.

The consultation submission date closes on 28 March.


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