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

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.