Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Keidanren Calls for Clearer Classification Criteria for “Software as a Medical Device” to Promote Development
Japan’s biggest business lobby Keidanren stressed on October 19 the need to clarify the criteria for determining whether “software as a medical device (SaMD),” such as therapy apps and diagnostic imaging programs, will be classified as medical or non-medical devices.…
To read the full story
Related Article
REGULATORY
- Japan Has Limited Drug Pricing Cards to Play on MFN, Should Expand CEA: MOF Official
October 5, 2026
- RMPs to Become Statutory Requirement under PMD Act in May 2027
October 5, 2026
- Japan Panel Calls for Better Infrastructure to Expand RLT Access
October 5, 2026
- Drug Discovery Fund Cleared to Provide Funding to Startups
October 5, 2026
- MHLW Simplifies Repatha Optimal Use Guidelines
October 5, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…