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Consultation: Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process

28 February 2022

Opening date: 28 February 2022

Closing date: 28 March 2022

While the consultation is open you can make a submission at our TGA consultation hub.

We review the submissions carefully. After that the submissions and our decision will be available on the same page at the TGA consultation hub.

About this consultation

The Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals.

The proposed 'Priority Review' pathway will align with the pathway in place for medicines and offer a faster formal assessment pathway for biologicals in certain circumstances. This will allow consumers with life-threatening diseases or seriously debilitating conditions to access these treatments in less time, where the assessment results in a decision by the TGA to include the biological in the Australian Register of Therapeutic Goods (ARTG).

All recent TGA consultations can be found at the TGA consultation hub.