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Australia Seeks To Tighten Drug Shortages/Discontinuations Reporting

 
• By Neena Brizmohun

The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.

Pharmacy Pills And Box With Healthcare Store Shelf And Prescription
The TGA says it works closely with stakeholders to respond to drug shortages and limit their impacts

Drug sponsors operating in Australia may in the future have to provide 12 months’ notice to the Therapeutic Goods Administration of a decision to permanently discontinue supplying any reportable medicine in Australia, according to proposals by the regulator.

Key Takeaways
  • Drug companies and other pharmaceutical stakeholders have until 13 Jan 2025 to comment on the proposals that the Therapeutic Goods Administration believes will improve its regulatory framework for medicine shortages and discontinuations.
  • One of the proposals would mandate a streamlined 12-month notice period for discontinuations of any reportable medicine included in the Australian Register of Therapeutic Goods

In addition, a greater number of critical non-prescription medicines could be added to the list of reportable drugs, which would require the sponsors of those

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