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  • Expanded ¡®pre-notification for change approval¡¯
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Mar 25, 2024 05:59am
to include supply disrupted drugs
Since last December, the MFDS has been operating the pilot system for over a year
The pilot system will be applied to new drugs, orphan drugs, and cutting-edge biomedicines¡ædrugs requiring reports of production, imports, and supply disruptions
The pilot system for ¡®pre-notification for pharmaceutical change approval,¡¯ which allows companies to predict the schedule of post-approval changes, will now applied to pharmaceuticals required for reporting production, imports, and supply disruptions.

Since December 18th of last year, the Ministry of Food and Drug Safety (MFDS) has been implementing a pilot system for pre-notifying processing post-approval changes. The system was designed to consider the product¡¯s manufacturing and import schedule and process the application within the due date specified by the applying company.

Previously, post-approval changes were processed without notification once the MFDS completed the review according to the approval a
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