SEOUL — South Korea’s primary drug regulator is moving forward with a significant restructuring of its approval and evaluation fees, targeting sharp increases for cutting-edge therapies and complex medical products.

The Ministry of Food and Drug Safety (MFDS) announced Friday that it has initiated administrative and legislative notice periods for revisions to the enforcement rules governing advanced biopharmaceuticals and drug approval fees. Under the proposed adjustments, regulatory costs for high-tech medical products and supplemental data submissions will climb substantially.

Industry stakeholders will face steep hikes across various categories. Product authorization fees for advanced biopharmaceuticals and novel biologics are set to jump approximately 2.6-fold, shifting from 8.3 million won to roughly 20.7 million won.

The change is even more pronounced for data-submission drugs—pharmaceuticals requiring supplementary data packages—which will see their approval fees surge more than sixfold, from 2.6 million won to over 16 million won. Concurrently, related application modification fees will triple to 7.7 million won.

Preliminary consultation fees are also slated for upward adjustment. The cost for safety and efficacy pre-reviews will nearly triple for novel biological products and multiply over seven times for data-submission items.

Regulatory officials noted that the revisions are driven by the rising technical complexity of submissions. Modern drug applications increasingly incorporate sophisticated clinical datasets, advanced biostatistical analyses, and intricate manufacturing quality data, placing heavier workloads and higher technical demands on evaluating personnel.

The latest adjustments build on previous regulatory updates by the MFDS, which recalibrated approval fees for completely novel therapeutics and biosimilars to higher tiers.

By upgrading its revenue structure, the ministry hopes to secure funding to recruit top-tier scientific talent, expand its roster of expert reviewers, and streamline the evaluation pipeline for advanced medical innovations.

Public feedback on the proposed regulatory changes is currently open, with deadlines set for late November and mid-December, depending on the specific notice category.

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