Expanded ‘pre-notification for change approval’

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→drugs 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 and review procedure.

 

This made it difficult for applying companies to predict the date of change approval.

 

The system has been updated to make the drug approval system flexible and reasonable.

 

Starting this year, the MFDS pilot system for ‘pre-notification for pharmaceutical change approval’ will be expanded to drugs requiring reports of production, imports, and supply disruptions.

The pre-notification system for post-approval changes, piloted until December 31st, includes the processing of change approvals for new drugs, orphan drugs, and cutting-edge biomedicines past the legal processing due date.

 

Starting this year, the system will be expanded to include pharmaceuticals requiring reports of production, import, and supply disruptions, in order to ensure a stable domestic supply of pharmaceuticals.

 

The list of pharmaceuticals subject to reporting production, import, and supply disruptions, posted annually by the Health Insurance Review and Assessment Service (HIRA), includes about 2,805 items (excluding duplicates) as of 2023, including anticancer drugs with 1-2 suppliers.

 

Companies that wish to be pre-notified for pharmaceutical change approval can select ‘yes’ to the ‘modification of change date’ when filing an application to the MFDS.

 

When adjustment dates were not specified at the time of application, companies can apply for the system via official letter until seven days before the processing deadline.

 

If a company wishes to request a modification to the post-approval change date, it must specify the date after the legal processing date.

 

For example, if the application's total processing period is 50 days, the company can specify the date within 50 working days of the processing deadline.

 

However, companies cannot shorten the processing duration through this system because it was designed not to affect the existing approval review process.

 

The pre-notification system only applies to cases where the application processing has to be delayed (extended) beyond the original processing deadline due to the drug's manufacturing or import schedule.

 

Modifications to change approval date (extension) can generally be applied to products, except when they fall under one of the following criteria: ▲restrictions to efficacy, method-of-use, and dose that relate to the safety of the product ▲a change in warning labels ▲or when requiring importance and urgency.

 

The MFDS will pilot the system until the end of December this year and decide on formal operation after an evaluation and review of the results.

 

“For pharmaceutical, we receive many requests for simple changes or extension of the deadline for drugs with confirmed approval,” an official from the MFDS stated.

 

“The pre-notification system is an additional administrative procedure designed to aid the industry.

 

So we encourage companies to apply for the system when they need it.”