India’s Ministry of Health and Family Welfare has proposed amendments to the 2017 Medical Devices Rules to simplify and speed up the licensing process for medical device manufacturing. A draft notification was published in the Official Gazette for public comment, with the... Read More
Japan’s health ministry wants to make it easier to bring repurposed drugs to market. At a July meeting, the Ministry of Health, Labour, and Welfare (MHLW) proposed a new filing category for medicines built on active ingredients whose reexamination period has already... Read More
China’s healthcare insurance authority has completed its preliminary formal review for this year’s adjustments to the National Reimbursement Drug List and the Commercial Health Insurance Innovative Drug List. This moves the annual process forward toward final listing decisions later this year. The... Read More
Japan’s annual economic policy blueprint, known as the “honebuto,” is expected to take a more proactive stance on pharmaceutical innovation this year. The 2026 draft includes a commitment to revisit how breakthrough medicines are priced at launch and how drug prices are... Read More
Taiwan’s Food and Drug Administration has advanced two notable regulatory updates this month. Registrants filing low-risk Class I devices may now use the agency’s Medical Device Premarket E-submission System, which eliminates the need for hard-copy documentation. In addition, the TFDA issued new... Read More
Japan has emerged as one of the more progressive markets when it comes to SaMD. While the concept of software-based medical tools is hardly new, the country’s formal regulatory recognition of SaMD reflects a deliberate effort to keep pace with the rapid... Read More
China’s National Medical Products Administration (NMPA) has issued a new announcement that refines how medical devices and in vitro diagnostic (IVD) reagents are classified and managed when classification changes occur. Announcement No. 52 establishes new guidance for handling classification adjustments. It is... Read More
Japan’s government has sounded the alarm over the United States’ most-favored-nation (MFN) drug pricing policy, warning it risks worsening the country’s longstanding struggles with its drug lag problem. Officials fear that as pharmaceutical companies grow more cautious about entering the Japanese market, where... Read More
Hong Kong’s Medical Device Division has updated its document checklist for medical device listing applications under the Medical Device Administrative Control System (MDACS). The MDACS framework requires all medical devices supplied in Hong Kong to demonstrate compliance with internationally adopted safety, quality,... Read More
Japan’s health ministry is urging pharmaceutical companies to choose institutional review boards (IRBs) carefully, as the country prepares to overhaul its Good Clinical Practice rules. The forthcoming revision, due to be promulgated this summer, will allow trial sponsors to directly select a... Read More