Device Firms Should Prepare For New Recall Policies, Australia’s TGA Says

Reforms To Come Into Effect In March

The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.

Australia Flag Doctor
Doctors in Australia will now prescribe by active ingredient • Source: Shutterstock

Australia’s Therapeutics Goods Administration is calling on drug and medical device companies to familiarize themselves with a preview of the final package of its product recall reforms that will be implemented in early March.

Key Takeaways
  • Australia’s Therapeutics Goods Administration has released a preview of the final package of its product recall reforms that will be implemented in early March.
  • The new Procedure for Recalls, Product Alerts and Product Corrections (PRAC) is expected to reduce regulatory burden for sponsors by minimizing administrative tasks while improving the timeliness of recalls, alerts and corrections

The new procedure, which will be called the

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