[Edaily Reporter NA EUN-KYUNG ] “While it was certain that we would receive a response from the U.S. Food and Drug Administration (FDA) within 30 days, I got the impression that the review process at the Ministry of Food and Drug Safety (MFDS) had a relatively loose timeline. From our perspective, we had no idea when a response would come and had to wait indefinitely, which was frustrating.”

An official at a biotech startup who has experienced both the U.S. Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety’s review of Investigational New Drug (IND) applications for the same candidate compound cited “predictability” as the biggest difference between the two agencies.

If the IND review is delayed, the schedules for contracting with clinical trial sites, recruiting patients, and producing investigational drugs are also pushed back. For biotech startups with limited financial resources, a wait of several months can lead to increased clinical costs and delays in securing follow-up investment. Even if the Ministry adheres to the statutory processing period, the time companies spend preparing supplemental data is excluded from the review period, resulting in a significant discrepancy in the perceived timeline for both parties.

Would Adopting the FDA’s Approach Solve the Problem?…“Securing Review Experts Comes First”

The Ministry of Food and Drug Safety (MFDS) recently announced a legislative proposal to shorten the statutory processing period for INDs deemed suitable following a preliminary review from the current 30 days to 10 days. However, the pharmaceutical and biotech industries have criticized the move, arguing that it merely reduces the nominal processing time for a subset of applications that have already undergone preliminary review. They argue that simply shortening the processing period while leaving key bottlenecks—such as repeated requests for additional information and a shortage of specialized reviewers—unaddressed will not effectively reduce the waiting time experienced by companies.

The FDA focuses its safety risk reviews on medical reviewers who possess clinical experience and expertise in the diseases targeted by the drug in question. If serious concerns are identified, the agency issues a clinical hold; otherwise, companies can begin clinical trials 30 days after submitting an IND.

Professor Lee Jang-ik of Seoul National University’s College of Pharmacy, who previously served as a clinical pharmacology reviewer and team leader at the FDA, explained, “What the FDA considers most important during the IND review process is the results of toxicity tests.” He added, “They focus on whether the manufacturing process could pose safety issues, what toxicity was observed in animal studies, and what risks it may pose to humans.”

Issues unrelated to safety are addressed through recommendations to improve the clinical trial design. Professor Lee said, “If the risk to subjects is too great, a ‘clinical hold’ is imposed; however, if the problem is not that serious, the process concludes with notifying the company on how to make adjustments to ensure meaningful clinical results can be obtained.”

However, Professor Lee drew a clear line, stating that simply changing the domestic system to a risk-based approach like the FDA’s would not solve the delay problem. He pointed out, “The fundamental reason why the Ministry of Food and Drug Safety (MFDS) cannot review INDs quickly with a focus on safety is an absolute shortage of specialized reviewers with the capability and experience to assess the safety of clinical trial protocols.” Ultimately, this means that before changing the structure of the system, the human resources needed to operate it must first be secured.

The FDA Has a Deep Pool of Medical Reviewers… But the MFDS Is Severely Lacking in Full-Time Physicians

Other industry experts also agreed that there is a shortage of medical experts to review clinical trial processes. A regulatory expert formerly with

the MFDS

recalled, “I remember that when I worked there several years ago, there were only about two or three physicians in the entire agency.” Kang Yun-hee, a former member of the MFDS Clinical Review Committee, also pointed out, “To my knowledge, there are currently no full-time physicians within the MFDS, and it is common for physicians hired on fixed-term contracts from outside the agency to resign before completing their terms.” In contrast, the FDA has well over 1,000 review staff with medical backgrounds.

According to federal workforce statistics from the U.S. Office of Personnel Management as of July 2026, there are 1,563 medical officers employed by the FDA. Medical officers are a specialized federal government profession that requires a medical degree; they are responsible for evaluating clinical data and the safety and efficacy of drugs, as well as formulating healthcare policies. While this does not mean that all 1,500 or so are involved in IND reviews, it shows that the organization as a whole has a far greater number of medical professionals than the MFDS.

Another issue is that these hard-to-recruit professionals often do not remain within the organization to accumulate review experience. A regulatory expert formerly with the Ministry of Food and Drug Safety explained, “Even when we recruited physicians, many tended to leave for the private sector after gaining clinical and regulatory experience, rather than working as reviewers at the Ministry for an extended period.” He added, “Since new drugs are constantly evolving, physicians must continue to study and gain experience even after obtaining board certification, but in Korea, it is difficult to retain that expertise within the organization.”

The shortage of experts leads to a mismatch between authority and responsibility. According to Professor Lee, non-full-time physicians currently participating in reviews do not hold the final decision-making authority or bear the corresponding responsibility, even when they provide professional opinions. In contrast, full-time civil servants who make the final decisions face intense scrutiny and accountability if problems arise. Former MFDS officials diagnose the situation as follows: in Korea, when problems arise in clinical trials, MFDS civil servants tend to be held accountable before the companies involved, which inevitably leads to a conservative approach to review.

Regarding this, Professor Lee pointed out, “Those with the expertise to make judgments should hold both the authority and the responsibility, but the current structure does not reflect this.” He also emphasized that if decision-making authority were granted to individuals with the appropriate expertise, they should not be held to excessive accountability. This is because if individuals are excessively held accountable based solely on the outcome of their judgments, reviewers will be forced to make defensive decisions—such as repeatedly requesting additional data—rather than actively reaching conclusions.

Instead, he argued that companies should be held to a much higher standard of accountability. If a company intentionally omits unfavorable toxicity data or submits false information, strong sanctions—including criminal penalties—must follow. Professor Lee stressed, “If a reviewer fails to request necessary data, that is a problem with the review agency; however, if a reviewer requests data essential for safety assessment and the company deliberately fails to submit it or fabricates it, the company must be held strictly accountable.”

Ultimately, it is just as important to ensure that these professionals remain within the organization and accumulate review experience as it is to recruit new experts. This means that, beyond simply improving working conditions, the personnel and career systems must be overhauled so that the role of a reviewer is established as a profession where experts can build long-term expertise, rather than a position where they gain short-term experience and then leave. An official in the biotech industry said, “Not only are there few doctors who join with the intention of continuing to work as MFDS reviewers from the outset, but many also leave because they cannot adapt to the organizational culture unique to government agencies,” adding, “Rather than attributing this solely to individual issues, comprehensive organizational improvements are needed to ensure that specialized personnel can settle into the organization.”