Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Japan to Obligate Single IRB in Multi-Center Clinical Trials That Use Competitive Funds
The Japanese Cabinet on June 21 gave its approval to the annual implementation plan for regulatory reform, in which it called for making the use of a single institutional review board (IRB) mandatory in publicly funded joint drug research. The…
To read the full story
Related Article
- Govt’s New Capitalism Council Proposes Extending Scope of Mixed-Billing Scheme
June 11, 2024
- Make Single IRB Mandatory in Multi-Center Trials That Use Competitive Funds: Deregulation Panel
June 4, 2024
- Expand Mixed-Billing Scheme to Cover Gene Panel Test: LDP Committee Proposal
May 31, 2024
- Expand Mixed-Billing Scheme, Use of Private Payers: LDP Healthcare Reform Team
May 20, 2024
- Apply Elective Care Scheme to Original Biologics with Biosimilars: Professor to LDP
May 10, 2024
- New LDP Project Team Boots Up for Healthcare Transformation
May 8, 2024
- Consolidate IRBs to Streamline Clinical Trials in Japan: Govt Working Group
March 11, 2024
REGULATORY
- Japan Govt Council Discusses Draft Recommendations for National MCM Strategy
December 9, 2025
- MHLW Eyes Govt-Led Ingredient Lists for Regional Formularies: LDP Briefing
December 9, 2025
- JMA Pushes Back on Incentives Tied to Regional Formularies: Chuikyo
December 9, 2025
- 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
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…