Korea’s Ministry of Food and Drug Safety (MFDS) is advancing a “full-cycle regulatory system” for rare disease drugs to reduce delays and improve patient access. Rare disease drug development is often hindered by small patient populations and limited clinical data, making trial-and-error... Read More
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... Read More
On January 15, Singapore’s Health Sciences Authority (HSA) and the Indonesian Food and Drug Authority signed a Memorandum of Understanding (MoU) to improve regulatory cooperation. Both agencies have obtained the World Health Organization (WHO) Listed Authority status, which confirms that they have met... Read More
Approximately 50% of global clinical trials are conducted in the Asia Pacific region today. The clinical trial landscape of Asia has been expanding beyond China in recent years. Although over 60% of the clinical trials in the region were initiated in China... Read More
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