TGA Adjusts Mandatory Shortage Reporting Window Based on Stakeholder Feedback

Australia’s Therapeutic Goods Administration has updated its plan for mandatory drug shortage reporting based on public comments in response to an April request.

The plan would require drugmakers to report key information about shortages of their products within a set time window, including special requirements for products on a watch list for drugs whose shortage could be life-threatening.

Stakeholder feedback was broadly supportive of better management and timely communication of drug shortages, but numerous comments said the two-day reporting window would not provide enough time to report shortage information to the agency.