Korea has introduced a series of regulatory measures aimed at modernizing its pharmaceutical regulatory framework and improving patient access to innovative products. Recent initiatives from the Ministry of Food and Drug Safety (MFDS) and other health agencies reflect a strategy to incorporate digital technologies into regulatory evaluation, increase transparency, and accelerate the availability of advanced treatments, especially in oncology and rare diseases.

Faster Reviews and Expanded Access to Rare-Disease Treatments

The MFDS has outlined plans to significantly shorten approval timelines for drugs, biosimilars, and medical devices as part of its 2026 administrative agenda. Biosimilar review periods, for example, will be reduced from more than a year to roughly eight months through measures such as parallel reviews, expanded pre-submission consultations, and dedicated review teams. AI-assisted review tools will also be introduced to streamline data evaluation and documentation.

Access to treatments for rare diseases is another focus. Building on earlier efforts to stabilize the supply of essential medicines and import unapproved therapies for urgent use, authorities plan to formalize humanitarian access pathways for high-cost orphan drugs. Under the proposed framework, companies could provide such medicines at no cost before reimbursement begins. Administrative requirements for patients would be simplified as well.

Broadened Eligibility for Cancer Clinical Trials

Korea is taking steps to expand access to oncology clinical trials by allowing participation at earlier stages of disease. Previously, most trials were limited to patients who had exhausted all approved treatment options. Under the new approach, patients who still have standard therapies available may enroll in trials if their participation is considered medically appropriate by physicians and patients.

Regulators say the change reflects a growing emphasis on patient choice and the potential benefits of earlier exposure to innovative therapies, including targeted treatments, antibody-drug conjugates, and immunotherapies. Updated guidance on selecting participants for early-stage cancer trials will be issued soon. The policy shift is also intended to strengthen clinical research by enabling earlier data collection, which could help accelerate the development and approval of promising cancer drugs.

Pricing Reforms to Support Innovative Medicines

Korea is revisiting its national health insurance drug pricing policies to improve access to high-value therapies. The government has proposed adjustments to the implicit incremental cost-effectiveness ratio (ICER) benchmark used in reimbursement decisions, acknowledging that existing thresholds may not reflect current medical advances. Authorities are considering raising the benchmark and developing a more flexible framework, with detailed policy proposals expected after further study.

A new weighted ICER approach is under discussion, which would take into account factors such as disease severity, clinical benefit, and budget impact. Over the long term, Korea is exploring a “list first, evaluate later” model that would allow certain innovative drugs to be reimbursed earlier. The pricing of drugs will be refined later based on real-world evidence.

Expanding Use of AI and Data Analytics in Regulatory Review

The Korean Ministry of Food and Drug Safety (MFDS) is working to implement greater use of artificial intelligence (AI) and data analysis in both drug reviews and post-marketing surveillance. The MFDS plans to start utilizing AI for various aspects of the drug evaluation process in 2026, starting with repetitive tasks such as collecting and organizing the necessary review materials for drugs. The MFDS anticipates that the use of AI will expand to other areas in the future as more structured regulatory data becomes available. The National Institute for Food and Drug Safety Evaluation (NIFDS) is spearheading efforts to implement these initiatives, while other divisions of the MFDS are exploring how to use big data methodologies to evaluate the risks associated with overseas GMP inspections. However, inconsistent data standards from foreign manufacturing facilities remain a challenge for these initiatives.

Meanwhile, the Korea Institute of Drug Safety and Risk Management (KIDS) is transitioning from a mostly manual to a largely predictive, data-driven pharmacovigilance system. Some of the proposed actions include automatic reporting of adverse events, digital compensation methods for patients, and real-time monitoring of safety signals by using electronic medical record (EMR) data. Over the next three years, KIDS’ shared data model will expand to dozens of additional hospitals and incorporate unstructured data to enhance signal detection. Additionally, KIDS plans to implement large language model-based tools to support the evaluation of drug safety, as well as develop an AI-powered chatbot to assist patients with filing compensation claims. Finally, paper drug safety cards are expected to be replaced by digital drug safety cards, which will be continuously updated with drug safety information. These measures come as a result of a surge in adverse event reports from Korea, which has become one of the top contributors to the WHO global safety database.

Transparency in GMP Inspection Findings

The MFDS has updated its approach to disclosing GMP inspection results. Under this new framework, the agency will now release complete GMP inspection copies and will only withhold information considered proprietary. All requests for confidentiality will also be evaluated more closely. Results from GMP inspections will also have new designations of “serious,” “important,” or “minor,” and all inspection results will indicate whether the GMP inspection results will lead to significant administrative actions and whether corrective actions are required.

Only the responsible inspection body and department will be identified, while the names of the Korean inspectors will not be disclosed. Finally, the MFDS is also standardizing inspection criteria by dosage form for finished products and by manufacturing process for active pharmaceutical ingredients to ensure consistency across compliance certificates.

Conclusion

These recent initiatives indicate that Korea is pursuing a comprehensive modernization of its pharmaceutical regulatory and reimbursement systems. By incorporating AI into review and safety monitoring, increasing transparency in GMP oversight, expanding clinical trial access, and introducing more flexible pricing, Korea is seeking to balance innovation, patient safety, and timely access to new therapies.