Japan’s FY2024 pharmaceutical sales revealed a sharp divergence among immune checkpoint inhibitors as MSD’s Keytruda (pembrolizumab) surged toward the 200-billion-yen…
REGULATORY
Japan’s Amended Next-Gen Medical Infrastructure Law Takes Effect
The Diet-enacted amendment of the so-called next-generation medical infrastructure law was enforced on April 1, creating a new category of data called “pseudonymized medical information” with a view to its use in regulatory submissions. The amendment of the law, formally…
To read the full story
Related Article
- AZ Wins Certification to Allow Use of Pseudonymized Medical Info
March 6, 2025
- Pseudonymised Data Should Fuel Orphan Drug Discovery, but Criteria and Overseas Usage Must Be Discussed: JPMA
July 21, 2023
- Japan Diet Ends Ordinary Session, All 7 MHLW-Submitted Bills Enacted
June 22, 2023
- Lower House Clears Bill to Amend Next-Gen Medical Infrastructure Law
April 14, 2023
REGULATORY
- Japan Panel to Review MSD’s 21-Valent Pneumococcal Shot, Silgard 9 for Male Use and More Label Expansions
July 18, 2025
- Japan Approves Reimbursement for CureApp’s Alcohol Reduction Digital Therapeutic
July 17, 2025
- Japan Begins FY2026 CEA Reform Talks, Re-Designation after Market Expansion Up for Debate
July 17, 2025
- Astellas Employee Sentenced to 3.5 Years in China for Spying
July 17, 2025
- Verdict Due July 16 for Astellas Employee Detained in China
July 14, 2025
I recently attended a fantastic conference hosted by Prospection Japan, and one speaker, Dr. Joe Ledsam, really blew me away with his insights. He shared some truly fascinating developments about how AI is set to revolutionize healthcare, from how doctors…
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 key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…