Japan’s market for Software as a Medical Device (SaMD) is on track for remarkable growth, expanding from approximately 20 million USD in 2024 to more than 95 million USD in 2033. From 2025 through 2033, the SaMD market is forecasted to grow... Read More
China’s National Medical Products Administration (NMPA) has published the draft Good Clinical Practice for Drugs (2025) with fundamental changes to further enhance participant protection, data integrity, and trial quality. Published at the end of October, 2025, this draft condenses the current eight-chapter... Read More
As mentioned last month, drug pricing negotiations are now underway in Japan, in line with the Fiscal System’s Council guidance for the FY2026 budget. In contrast to the Japan Pharmaceutical Association’s desire for higher prices, the Japanese Ministry of Finance (MOF) is... Read More
On November 4, the National Medical Products Administration (NMPA) released its revised Good Manufacturing Practice (GMP) for medical devices, which will come into effect on November 1, 2026. This is the first major revision of the GMP since 2014, and forms part... Read More
For the first time, India’s Central Drugs Standard Control Organization (“CDSCO”) has issued a Draft Guidance on Medical Device Software to regulate software-based medical devices, including AI-based devices. This guidance aims to clarify the classification, licensing, validation, and post-marketing surveillance of Software... Read More
A new regulation issued by China’s State Council outlines, for the first time, clear rules for the study and use of advanced biomedical technologies, including gene editing, CAR-T and NK cell therapies, as well as stem cell treatments. The Regulations on the... Read More
Singapore’s Health Sciences Authority (HSA) has officially opened its new electronic Common Technical Document (eCTD) portal for test submissions. This represents an important move towards the process of digitalizing regulatory submissions for therapeutic products. The eCTD Specification Package version 1.0 will be... Read More
Japan is the world’s third-largest device market. Similar to the drug lag, Japan is now beginning to see a device lag. The reason for this is that although Japan wants and needs innovative devices for its citizens, especially innovative devices that will... 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 Government of India has issued the Legal Metrology (Packaged Commodities – “LMPC”) Amendment Rules, 2025, a pivotal reform that exempts medical devices from the purview of the LMPC Rules, 2011. The amendment puts to rest long-standing issues of overlap created by... Read More