Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Lower House Clears Bill to Amend Next-Gen Medical Infrastructure Law
Japan’s Lower House approved a draft bill to amend the next-generation medical infrastructure law on April 13, which would create a new category of data called “pseudonymized medical information” with a view to its use in regulatory submissions. The bill…
To read the full story
Related Article
- AZ Wins Certification to Allow Use of Pseudonymized Medical Info
March 6, 2025
- Japan’s Amended Next-Gen Medical Infrastructure Law Takes Effect
April 2, 2024
- Japan Diet Ends Ordinary Session, All 7 MHLW-Submitted Bills Enacted
June 22, 2023
- MHLW Planning to Submit 6 Bills in Ordinary Diet Session, “Japan CDC” Plan Included
January 13, 2023
- “Pseudonymized Medical Info” to Be Created to Fuel Healthcare Data Use in Filing
January 5, 2023
- Working Group Urges Govt to Discuss Use of Anonymized Medical Data for Regulatory Purposes
June 2, 2022
REGULATORY
- PMDA to Adopt General-Purpose AI in FY2025, Eyes Specialized Tools for Reviews and Safety Work
December 8, 2025
- Japan Likely to Extend Generic-Name Prescribing Premium to Biologics to Spur Biosimilars
December 8, 2025
- Aspirin, CAR-T and Other Products under PMDA Safety Review
December 8, 2025
- R&D Tax Credit Draws Broad Calls for Maintenance, Expansion: LDP Meeting
December 8, 2025
- Another LDP Study Group Submits Emergency Proposal Urging Drug Pricing Overhaul
December 5, 2025
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
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…