Prior notification of drug permit changes extended to 2025

The operation of the 'Advance Notification System for Drug Change Permit' will be extended to December next year

Includes drugs whose production, import, and supply interruptions were subject to reports in May

The operation of the pilot program, 'Advance Notification System for Drug Change Permit', which allows drug manufacturers and importers to apply for change permits on their preferred date, will be extended.

 

According to industry sources on the 18th, the Ministry of Food and Drug Safety (MFDS) will extend the pilot project until December 31 next year to collect sufficient data to evaluate the system and in consideration of industry demand.

 

The Advance Notification System for Drug Change Permit is a system in which the MFDS and drug manufacturer/importer discuss the date of a drug’s permit change in advance, taking into account the manufacturing and import schedule of the company before processing the change, and then approving the change according to the applicant's desired date.

 

The system had been operated only for new drugs, orphan drugs, and advanced biopharmaceuticals until now.

 

Still, as of May 30, the system had been expanded to include drugs subject to production, import, and supply interruption reports.

 

In the case of drugs subject to production, import, and supply interruption reports, their inclusion in the system may be subject to change according to the list announced by the Health Insurance Review and Assessment Service in late December.

 

Drug manufacturers and importers must obtain a change permit from the head of the MFDS when changes are made to authorized drugs, and then manufacture and import products reflecting the changes.

 

Previously, when the MFDS’s approval process for a drug permit change application was completed, its approval was processed without any notification, making it difficult for companies to predict the date of approval.

 

To address this, the MFDS has established an advance notification system for drug permit changes and plans to institutionalize it through evaluation after completion of the pilot program.

 

The system allows a company that applies for a change permit and enter a notice of the desired change period into the NEdrug system after the MFDS completes review.

 

The change date must be set after the statutory deadline, and extensions can be requested within the statutory period of the civil complaint.

 

Adjustment of the date of change approval through the advance notification system is only applicable to cases where it is necessary to process (extend) the period later than the original processing period due to the manufacturing and import schedule of the drug in question in order not to affect the existing approval process.