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

Overview

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 if the assessment results in a decision by the TGA to include the biological in the Australian Register of Therapeutic Goods (ARTG).

We are seeking feedback on:

• whether you support the introduction of a priority pathway for biologicals
• the proposed eligibility criteria for the Priority Review pathway for biologicals
• the proposed process for determining whether a biological application meets the eligibility criteria for Priority Review (the ‘Determination Process’).

Consultation paper

This consultation paper outlines the proposed eligibility criteria, determination process and other considerations including fees and charges.

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

Making a submission

To make a submission:

1. Read the consultation paper about the proposed Priority Review pathway (see link above).
2. Go to the online consultation questions (see ‘Give us your views’ below), complete and submit your response.

Why your views matter

There is currently no formal mechanism to expedite the assessment and inclusion of biologicals in the ARTG.

We are seeking your input on whether a priority pathway should be established and, if so, if the proposed Priority Review pathway is suitable. We are seeking your feedback to make sure the proposed priority pathway:

• assists in achieving faster assessment and earlier access to certain novel and life-saving biologicals that address unmet clinical needs for Australian consumers
• provides timely and flexible registration processes for sponsors seeking access to the Australian market for new and novel uses of biologicals that offer substantial benefits to Australian consumers
• increases alignment with other overseas regulators that offer accelerated assessment processes.

What happens next

We will review all feedback received in response to this consultation.

Depending on the feedback received, the TGA could propose to the Australian Government that a priority pathway be implemented for the pre-market assessment and registration of novel biologicals that address unmet clinical needs for Australian consumers. This would require changes to the Therapeutic Goods Regulations 1990.