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
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