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Oh Yu-kyoung, Minister of Food and Drug Safety, briefs reporters at the Government Complex Seoul on May 26. She outlined regulatory reform measures for the approval and review of new drugs and medical products, which follow up on the second presidential meeting on rationalizing core regulations. / Photo by Reporter Park Seong-il

The government will accelerate the approval process for new drugs, biosimilars, and cutting-edge medical devices to a world-class speed. The cornerstone of this initiative is slashing the required approval period to under 240 days. This target is overwhelmingly faster than the US Food and Drug Administration (FDA) at 300 days, the European Medicines Agency (EMA) at 365 days, and Japan's regulatory body at 365 days.

Minister of Food and Drug Safety Oh Yu-kyoung held a briefing at the Government Complex Seoul on May 26, announcing, "We will implement the 'Medical Product Approval and Review Innovation Plan' starting June 1. We intend to transform into a regulatory service agency that upholds safety more firmly than ever while advancing reviews at the world's fastest pace."

The crux of this innovation plan involves completely overhauling the entire approval lifecycle, from data compilation to application submission and review completion. The structure allows the Ministry of Food and Drug Safety (MFDS) to step in preemptively during the initial data compilation stage, lowering corporate burdens and picking up review speeds.

First, during the data compilation phase, sector-specific checklists will be distributed. Covering domains such as safety and efficacy, quality, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Risk Management Plans (RMP), these checklists will map out mandatory verification items prior to application filing, enabling companies to enhance the completeness of their dossiers independently.

Immediately preceding the application stage, a formal "Pre-New Drug Application (Pre-NDA) Meeting" framework will be officially institutionalized. Previously, preliminary inquiries by corporations were limited to a single oral consultation; moving forward, at least two formal face-to-face meetings will be organized to boost review predictability and expand communication channels.

During the actual review phase, a simultaneous and parallel review system driven by dedicated teams will be deployed. In the past, initial evaluation opinions were delivered 87 days after an application was received. Under the new system, first-round evaluation opinions on separate fields—including quality, safety, and efficacy—will be provided starting on the 25th day. This mechanism allows corporations to grasp required revisions early on and compile supplemental data swiftly.

The ministry has also drastically expanded its workforce. Last month, the MFDS recruited 195 new approval and review personnel, boosting its headcount from 369 to 564. Minister Oh emphasized, "While speed is important, safety remains our core value. A significant portion of the newly added personnel will be deployed intensively to safety evaluations to maintain a meticulous review framework."

Plans are also underway to introduce an artificial intelligence (AI) review assistance system. Starting with the raw material quality sector in the second half of this year, the system will scale up in stages to finished products next year, and to safety, efficacy, and clinical trial fields by 2028. Refinements to clinical trial approval protocols will be announced separately after gathering industry feedback.

The new measures will apply to companies filing new approval applications on or after June 1. Corporations with existing applications will proceed under the prior protocols.

"This innovation plan marks a significant turning point that fundamentally alters the review architecture and reinforces on-site communication throughout the entire pipeline from treatment development to final approval," Minister Oh remarked. "We will create an environment where the public can access innovative new drugs, biosimilars, and advanced medical devices much faster."

                                                                                                             Choi Jung-ah