On April 7, 2026, Beijing health authorities released a policy package with 32 measures to support innovative drugs and medical devices across the full lifecycle, from R&D to clinical use. Key actions include improving clinical trial infrastructure, accelerating regulatory review, and expanding... Read More
Singapore’s Health Sciences Authority (HSA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation in Tokyo on April 20, 2026. The agreement aims to bring the two regulators closer together in how they oversee drug products. At... Read More
Hong Kong launched Phase 1 of its new “primary evaluation” regime for drug registration on March 31, 2026. The change supports the creation of the Hong Kong Center for Medical Products Regulation and moves the country closer to a fully independent drug... Read More
China’s National Medical Products Administration (NMPA) has released a long-term strategy titled “Implementation Opinions on AI + Drug Regulation.” This ambitious regulation aims to integrate AI across the full pharmaceutical regulatory lifecycle by 2035. The roadmap defines two key milestones. First, by... Read More
Singapore’s Ministry of Health (MOH) has released new “Cybersecurity and Data Security Essentials” guidelines to support the rollout of the Health Information Act (HIA). The guidelines set out baseline requirements for healthcare providers handling patient data. They will be introduced in phases... Read More
Vietnam’s Ministry of Health issued “Consolidated Document No. 08/VBHN-BYT” on medical device management on March 6, 2026. This brings together the provisions of Decree No. 98/2021 and its amendments, including Decree No. 07/2023, into one unified document. The consolidation simplifies how device companies should interpret and... Read More
The Philippine Food and Drug Administration (FDA) has released a draft circular introducing clearer and more detailed post-market surveillance (PMS) requirements for medical devices. The proposal aims to strengthen traceability and improve how medical device safety issues are monitored and addressed. The draft is based on... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued new notifications clarifying how pediatric drug development will be handled under amendments to the Pharmaceuticals and Medical Devices Act. These notifications will take effect on May 1, 2026. The measures aim to strengthen... 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