MFDS Plans to Raise Drug Approval Fees by Up to Sixfold

"Aimed at improving the quality of approvals and reviews"

Approval fees for medicines that are subject to rigorous reviews, including advanced biopharmaceuticals, are expected to rise significantly. The move is intended to improve the quality of approvals and reviews by increasing the number of review staff.

Ministry of Food and Drug Safety in Cheongju, North Chungcheong Province. The Asia Business Daily DB

On November 6, the Ministry of Food and Drug Safety announced that it had issued legislative and administrative notices that day on proposed amendments to the “Rules on the Safety and Support of Advanced Biopharmaceuticals” and the “Regulations on Fees for Approvals of Pharmaceuticals and Other Products.”

Under the proposed amendments, product approval fees for advanced biopharmaceuticals and new biological medicines will each rise from 8.03 million won to 20.71 million won, while fees for medicines requiring data submissions will increase from 2.61 million won to 16.04 million won. This represents an increase of about 2.6 times for advanced biopharmaceuticals and new biological medicines, and about 6.1 times for medicines requiring data submissions.

Advanced biopharmaceuticals are medicines that use cell, genetic material, or tissue-engineering technologies, such as cell therapies and gene therapies. Medicines requiring data submissions are not new drugs but are subject to safety and efficacy reviews. Fees for changes to approvals and for preliminary reviews before submitting approval applications will also increase.

The Ministry of Food and Drug Safety is revising the fees because approval reviews are becoming increasingly difficult. Clinical, statistical, and quality-related data submitted with recent approval applications have become more complex and reflect the latest technologies, raising the difficulty of reviews and increasing the need for specialized staff.

A ministry official said, “We expect that bringing the fees in line with current needs will provide a basis for increasing review staff and improving the quality of approval reviews for medicines that require highly specialized assessments.” The official added, “Comments on the proposed amendments may be submitted by November 26 for the administrative notice and by December 16 for the legislative notice.”

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