Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Draft Growth Strategy Embraces Clinical Development Infrastructure, Drops Numerical Target for Sakigake System
A draft of the government’s new economic growth strategy calls on Japan to build a clinical development infrastructure by harnessing a national patient registry, but does not include a specific target for the so-called “sakigake” designation system eyed by the…
To read the full story
Related Article
- NCC Eyes Trial Enrollment of 150 Rare Cancer Patients under Registry Initiative
July 3, 2015
- Govt OKs Economic Growth Strategy, Regulatory Reform Plan
July 1, 2015
- LDP OKs Economic, Fiscal Policy Guidelines, but Wording on Reference Pricing Could Change
June 26, 2015
- LDP Begins Intraparty Deliberations on Economic, Fiscal Blueprint
June 24, 2015
- LDP Compiles Proposal for Govt Growth Strategy, Including Target for Sakigake System
June 12, 2015
- LDP Eyes Filing of 15 Sakigake Designated Products by FY2018
June 9, 2015
- LDP Weighs Clinical Development Infrastructure Utilizing Patient Registry
April 24, 2015
REGULATORY
- LDP Tax Panel OKs New 40% R&D Credit for Strategic Technologies
December 12, 2025
- Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
December 11, 2025
- 2024 Reform Spurred New Development Activity, 20 Projects Entered Clinic: Industry Poll
December 11, 2025
- Regenerative Medicine Group Accepts Deferred Debate on Market Expansion Re-Pricing
December 11, 2025
- Wholesalers Urge Price Hikes on Sub-20-Yen Drugs as Negative Margins Mount
December 11, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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…
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…