New expedited regulatory pathway proposed for novel biologicals


A new regulatory priority pathway has been proposed for novel biologicals, including human cell and tissue therapies, and AusBiotech is calling for feedback from affected members as it considers responding to the Therapeutic Goods Administration (TGA)’s consultation.

The proposed expedited pathway is for the assessment of certain novel and life-saving biologicals to enable patients with life-threatening diseases or seriously debilitating conditions to access these treatments quicker.

The ‘Priority Review’ pathway has been developed in recognition of the number of late-stage clinical and commercial products that industry is preparing to deliver for conditions with high unmet need, and has been designed to accommodate emerging and novel technologies.

The proposed pathway will be aligned with the pathway for medicines and will increase alignment with other overseas regulators offering accelerated assessment processes.

There is currently no formal mechanism to expedite the assessment and inclusion of biologicals in the ARTG. The new ‘Priority Review’ pathway aims to provide a predictable and transparent mechanism to formalise processes for sponsors and the TGA.

The TGA is seeking feedback on:

  • Support for the introduction of a priority pathway for biologicals;
  • the proposed eligibility criteria; and,
  • the proposed ‘determination process’ for whether a biological application meets the eligibility criteria.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

The public consultation is open until 28 March 2022, and Members are encouraged to contact Karen Parr, Communications Director, by Friday 18 March to discuss how the proposal may impact their company.

The TGA’s consultation papers can be read here.