While in the past, the US, EU, and Japan dominated the global medical device market, things are changing as more new devices are being developed in Asia first, especially in China. Accordingly, Korea and China have recently announced new initiatives aimed at... Read More
Korea has unveiled major reforms to its national health insurance drug pricing system to improve patient access to innovative medicines, especially for severe and rare diseases. Several weeks ago, the government submitted its “Proposal for Improving the Drug Pricing System” to the... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) plans to make its approval system the world’s fastest by sharply reducing review timelines for drugs, biosimilars, and medical devices under its 2026 administrative plan. Biosimilar reviews will be shortened from up to 420... Read More
Korea has recently rolled out a more robust series of regulatory reforms and actions aimed at streamlining patient access to cutting-edge medical technologies over the past year. The advances signal Korea’s growing ambition to become a global leader and incubator in the digital health and advanced medical device sectors. Market Access... Read More
Korea will significantly expand eligibility for cancer drug clinical trials, allowing patients who still have other standard treatment options to participate much earlier. The Ministry of Food and Drug Safety announced on Nov. 25 that participation would no longer be limited to... Read More
The Korean Ministry of Food and Drug Safety (MFDS) has made a major overhaul to its disclosure policies regarding Good Manufacturing Practice (GMP) inspection outcomes. The MFDS will now disclose results in full, instead of in the past, just issuing heavily redacted... Read More
A draft bill has been introduced in Korea to increase the scope of devices that can receive a designation as “innovative medical devices“. Innovative devices are those that would enhance the convenience and quality of diagnosis and treatment. At present, only devices with enhanced safety... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More
While China has dominated the headlines for new drug research and out-licensing to Western pharmaceutical companies, and will continue to do so in the future, Korea, too, is entering the new drug game. While historically Korean drug companies have mainly focused on making... Read More
Korea is quickly expanding the use of AI in its drug regulatory and safety systems. Korea’s Ministry of Food and Drug Safety (MFDS) will start applying AI in drug review work starting next year as part of a wider attempt to innovate its regulatory... Read More