Priority Review and Provisional Approval coming in Australia

The Therapeutic Goods Administration (TGA) in Australia is planning to introduce new procedures for priority review and provisional approval for prescription medicines and is currently consulting on the details.

Priority review will deliver faster assessment of dossiers for medicines for the treatment of serious and life-threatening conditions, thereby delivering quicker access these medicines if the assessment is positive.

Provisional approval will permit earlier access to promising new drugs that do not, at the time, have a full dossier of efficacy and safety data, but where there is potentially substantial benefit to patients based on the promising clinical results.

Comments are being sought on the proposed eligibility criteria and the process for determining that a medicine meets the eligibility criteria for the two procedures.

Our comments on the new procedures are:

  • It is encouraging to see that the TGA are proposing to streamline some of their registration processes.
  • The new procedures should benefit Australian patients with faster access to medicines for serious and life-threatening conditions.
  • The new procedures will bring Australia more closely in line with the EU and US where similar pathways already exist.

The consultation closes on 12th December 2016. For more information or to comment on the proposals, click here.