Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
8 Year Biologic Data Protection in TPP Won’t Affect Japan: MHLW Official
A dozen members of Trans-Pacific Partnership (TPP) trade talks effectively settled upon a data protection period of eight years for biologics, but this won’t have an impact on the current pharmaceutical environment in Japan, a senior health ministry official told…
To read the full story
Related Article
- JPMA Says Its Demands Generally Accepted in TPP, No Impact Expected on Japan Market
October 23, 2015
- Patent Extension, Patent Linkage Rules in TPP Require No Rule Changes in Japan: MHLW Official
October 20, 2015
- TPP Will Have No Impact on Japan’s Universal Care Scheme: Negotiator
October 9, 2015
- EFPIA Director General Welcomes Broad Deal Reached on TPP
October 7, 2015
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…