Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
REGULATORY
MHLW Presents Policy for Use of “Specified Clinical Research” Data in Regulatory Submissions
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on March 31, providing its basic policy and points to note for the use of results obtained from “specified clinical research” in regulatory submissions. Specified clinical research (tokutei rinsho…
To read the full story
Related Article
- MHLW to Make Case-by-Case Decisions on Use of “Specified Clinical Research” Data in Regulatory Filings
April 6, 2023
- MHLW Official Sees More “Specified Clinical Research” Data Used in Regulatory Submissions to Fill Industry-Academia Void
July 20, 2022
- NCC Doctor Hails MHLW’s Policy on Use of Clinical Research Data in Regulatory Filing
June 22, 2022
REGULATORY
- LDP’s Patch League Urges Finance Minister to Continue Coverage, Support Prices
December 16, 2025
- Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests
December 15, 2025
- LDP Leans Towards “Special Charges” for OTC-Like Drugs, Not Coverage Removal
December 15, 2025
- Ishin Urges “Special Charge” Scheme for OTC-Like Drugs, Eyes FY2026 Launch
December 15, 2025
- LDP Tax Panel OKs New 40% R&D Credit for Strategic Technologies
December 12, 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…