Medicine shortages and discontinuations: Proposed changes to reporting requirements

Overview

Medicines are essential for the health and wellbeing of Australians. Medicine shortages can occur for various reasons. Unfortunately, some are unavoidable and can cause significant impact.

Through our mandatory reporting scheme, the Therapeutic Goods Administration (TGA) receives and publishes reports of shortages and discontinuations of prescription and certain over-the-counter medicines. We work closely with our stakeholders to respond to shortages and limit their impacts.

In 2024, the TGA consulted extensively to better understand the challenges and barriers experienced by consumers, health professionals, industry and government resulting from medicine shortages and discontinuations. We heard that although improvements have been made, shortages and discontinuations continue to impact on the health and wellbeing of people in Australia, including the health professionals and systems that support them.

The TGA is investigating regulatory, digital and process improvements to the monitoring of medicine shortages and discontinuations in Australia, and to support mitigating actions. Under this program, we will work in collaboration with parties in the medicine supply chain to develop solutions to further reduce the impact of shortages and discontinuations.

Why your views matter

This consultation seeks your feedback on proposed improvements to TGA’s regulatory framework for medicine shortages and discontinuations in Australia. Specifically, proposals to:

1. Improve TGA’s monitoring of medicine shortages by:
    
   1. Adding more critical non-prescription medicines to the list of reportable medicines, which would require sponsors of those medicines to report shortages and discontinuations to the TGA; and
       
   2. Updating the Therapeutic Goods Act 1989 to enable the TGA to request detailed supply information from sponsors when needed about any approved medicine, not just reportable medicines.
2. Require sponsors to provide 12 months’ notice to the TGA of a decision to permanently discontinue supply of any reportable medicine in Australia.

These proposed changes are in response to feedback from the 2024 public consultation and market research about the challenges and barriers associated with medicine shortages and discontinuations.

Please contact us at shortages.strategy@health.gov.au if you have any issues with completing this survey.