Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
HOME > REGULATORY
REGULATORY
- J&J’s Lazcluze, Genmab’s Tivdak and More Drugs in Line for Japan Approval
February 28, 2025
- LDP, Komeito, Ishin Agree to Set Up Consultive Body for Social Security Reform
February 26, 2025
- Coordinate Patent Issues with Originators before Listing: MHLW to Generic Firms
February 26, 2025
- Care Avoidance from Copay Cap Hike Likely to Result in 195 Billion Yen Cost Reduction
February 25, 2025
- PMDA Lists Info Needed for Pediatric Development Plan Confirmation
February 25, 2025
- MHLW to Shorten Procedure for Generic Product Integration to 1.5 Months
February 21, 2025
- Takeda’s Livmarli, BMS’s Camzyos and More Up for MHLW Panel Review on March 6
February 21, 2025
- Japan to Pen Fact Sheet for Sanofi’s High-Dose Flu Jab
February 21, 2025
- Japan Approves CSL’s HAE Med Andembry, Tecentriq Sarcoma Use, and More
February 21, 2025
- Ex-Lawmakers Launch Council for Revamping Japan’s Drug Innovation
February 20, 2025
- Chuikyo OKs Pricing Rules for FY2025 Drug Price Revision
February 20, 2025
- CDP Submits Bill Calling for Outright Freeze on Copay Cap Reform
February 20, 2025
- Sakigake Tag Withdrawn for 2 Boehringer Drugs
February 20, 2025
- Pfizer Pulls Japan NDA for Hemophilia Gene Therapy Beqvez as Program Called Off Globally
February 20, 2025
- Ishiba Vows to Take Steps on OTC-Like Meds from FY2026, Freeze Certain Hikes in Copay Caps
February 19, 2025
- Japan Cabinet OKs 5-Year Healthcare Strategy from FY2025
February 19, 2025
- Minister Touts “Balanced” Off-Year Revision after USCC Letter
February 19, 2025
- Espha’s Januvia Generic on Approval Roster towards June Listing
February 18, 2025
- “Annual Reports” Allowed for CMC Changes with Minimal Impact: MHLW
February 17, 2025
- Japan to Approve EquMet Generics, More Copycats toward June Listing
February 17, 2025
ページ
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…