Previously, there was a challenge in predicting the approval date for changes, as once the review by the MFDS was completed for a change approval application, the approval process would proceed without separate notification to the company.
In response, the MFDS has announced the pilot operation of the Pre-notification System for Changes in Pharmaceutical Marketing Authorization starting from December 18th. This initiative aims to increase predictability for changes in drug authorization schedules and ensure a stable supply of pharmaceuticals in the domestic market.
The Pre-notification System for Changes in Pharmaceutical Marketing Authorization is a system in which the MFDS and pharmaceutical manufacturers or importers, prior to processing changes in product authorization, engage in pre-discussion with the applying company to consider the company's manufacturing or import schedule. Subsequently, the applying company submits a pre-notified application, allowing them to obtain the modification approval on the desired date.
The pilot project will be in operation until the end of December 2024, and a formal decision on whether to proceed with regular operations will be made after evaluating and reviewing the results of the pilot phase.
