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.
- One of the changes to be introduced via the PRAC includes reducing the number of steps in the recall process from 10 to five.
- The exact data of the PRAC’s implementation is to be announced soon.
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...
The new procedure, which will be called the Procedure for Recalls, Product Alerts and Product Corrections (PRAC), is designed to improve the timeliness of recalls,...
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