MFDS Transforms Drug Management System…'Constant Control' Era Begins
Local Time, March 26, 2026 – The Ministry of Food and Drug Safety (MFDS) has rolled up its sleeves to protect public health by announcing a 'constant control' plan to dramatically improve the drug management system. This announcement demonstrates the MFDS's strong commitment to ensuring drug safety by establishing a proactive and strengthened management system amid growing public concerns about drug safety.
No More 'After-the-Fact Remedies'…Paradigm Shift to 'Constant Control'
The existing drug management system has mainly relied on 'post-inspection' methods. It has been consistently pointed out that identifying and resolving the cause only after a problem occurs is not effective in responding to the rapidly changing drug market and increasingly diverse risk factors. Accordingly, the MFDS will introduce a 'constant control' system throughout the entire process from drug production to distribution and use, completely redesigning the system to proactively block potential risk factors and respond quickly to problems.
Three Core Pillars: Strengthening Monitoring, Impurity Management, and Overseas Manufacturing Site Management
This system redesign will proceed focusing on three core pillars:
1. Advancing the Monitoring System: Establishing a system that utilizes advanced technologies such as big data and artificial intelligence (AI) to analyze drug-related data in real-time and detect abnormal signs early. This will enable rapid identification and response to drugs with a high potential for side effects or illegally distributed drugs.
2. Strengthening Impurity Management: Strengthening management standards for impurities that may occur in drug raw materials and manufacturing processes, and expanding testing capabilities. In particular, it plans to introduce impurity analysis technology that meets international standards and focus on preventing drug safety accidents caused by impurities by training related experts.
3. Strengthening Overseas Manufacturing Site Management: Strengthening management and supervision of drugs manufactured overseas and imported into Korea. It will shorten the cycle of on-site inspections of overseas manufacturing sites and expand surprise inspections to improve the quality control level of overseas manufacturing sites. In addition, it will strengthen cooperation with overseas regulatory authorities to establish information sharing and cooperation systems, enabling rapid response to problems related to overseas manufacturing sites.
Strengthening Adverse Event Management for Biopharmaceuticals and Expanding Safety Evaluation of Combination Drugs
Safety management for biopharmaceuticals, which are increasingly being used, will also be strengthened. Biopharmaceuticals are more likely to cause side effects than chemical drugs, and it is difficult to determine the causal relationship when adverse events occur. Accordingly, the MFDS plans to strengthen the monitoring system for biopharmaceutical adverse events and establish a response system to quickly identify the cause and take necessary measures when adverse events occur.
In addition, safety evaluations for combination drugs containing herbal and chemical ingredients will also be expanded. There have been concerns that herbal ingredients may cause unexpected side effects due to interactions with chemical ingredients. Accordingly, the MFDS plans to strengthen safety evaluations for combination drugs and, if necessary, conduct additional clinical trials to ensure the safety of combination drugs.
Holding Policy Briefings…Enhancing Policy Understanding Through Strengthened Communication
The MFDS plans to hold policy briefings related to this drug management system redesign to strengthen communication with various stakeholders, including the pharmaceutical industry, medical experts, and civic groups. The policy briefings will provide detailed explanations of the content and application methods of the new system, related regulations, etc., and will provide an opportunity to resolve questions and collect opinions through Q&A sessions. The MFDS plans to increase understanding of the new system through these communication efforts and promote the successful establishment of the policy.
Expert Opinion: “Welcome Change…Continuous Investment and Attention Needed”
Drug safety experts are generally reacting positively to the MFDS's announcement. One expert said, “The existing post-regulation-centered drug management system has made it difficult to meet the public's increased safety demands,” and evaluated that “the introduction of a constant control system is a welcome change.” However, he emphasized that “continuous investment and attention are needed for the new system to be successfully established,” and added that “efforts in various fields, such as the introduction of advanced technology, training of professional personnel, and reorganization of related regulations, must be supported.”
MFDS's Efforts to Protect Public Health, Attention to Future Actions
This drug management system redesign is an important step demonstrating the MFDS's commitment to prioritizing public health. Attention is focused on whether the 'constant control' system announced by the MFDS will be successfully established and create an environment where the public can use drugs with confidence.
