Korea operates one of the most tightly managed drug pricing systems in the Asia-Pacific region. Since adopting a “positive list system” in 2006, the country has required every new drug to prove its value before it can be listed on the National... Read More
Korea’s drug regulator is moving on two fronts to speed approvals and cut red tape for the medical sector. On July 31, the Ministry of Food and Drug Safety (MFDS) said that it would streamline the process for converting orphan drugs into... Read More
Korea’s Ministry of Health and Welfare announced on June 30 a pilot program to speed up health insurance listing for rare disease treatments. The process will take only 100 days, down from 240 days. Under the pilot, cost-effectiveness assessments will happen after... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) revised its digital medical device labeling guidelines on June 10. The update follows industry difficulties after the Digital Medical Products Act took effect in January 2025. Key changes include a grace period permitting previous... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) is expanding regulatory support for developers of cell and gene therapies by broadening its pre-consultation program to include products in the nonclinical stage. Previously, the service mainly focused on companies preparing for clinical trials.... Read More
Korea’s Ministry of Health and Welfare (MOHW) announced a new funding program on April 10, 2026. The initiative is designed to speed up the commercial rollout of AI-based medical devices. It focuses on the post-approval phase, where many products encounter challenges, as... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) has issued a draft revision to the Enforcement Rule of the Medical Devices Act that would streamline device change procedures and update several regulatory requirements. The revision introduces the “negative list” system for device... Read More
A new trade agreement between the United States and Taiwan includes measures to expedite the regulatory review of innovative pharmaceuticals and medical devices manufactured in the US. Under the agreement, approval from the US Food and Drug Administration may be used as... Read More
Korea is moving to significantly accelerate patient access to rare disease therapies. This is a result of a sweeping overhaul of its national drug pricing and reimbursement system, approved by the Health Insurance Policy Deliberation Committee. The reform introduces a fast-track pathway that... Read More
Korea is developing an AI–supported system to assist regulatory drug reviews. The initiative, led by the Ministry of Food and Drug Safety (MFDS), includes a task force to build generative AI tools that can help analyze regulatory submissions, automate repetitive review tasks,... Read More