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 acc