Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- Need of Placebo-Controlled Studies Will Be Decided on Case-by-Case Basis: PMDA Official
January 20, 2016
- Seriousness of Target Diseases, Efficacy Became Key in Sakigake Designation: MHLW Official
January 20, 2016
- Drug Makers Told to Check Conformity of Manufacturing Process with Approved Methods
January 20, 2016
- PAFSC’s 2nd Committee to Review Novartis’s Melanoma Drugs on Feb. 1
January 20, 2016
- “Huge Seller” Re-Pricing to Hit Sovaldi, Harvoni, Avastin, Plavix
January 20, 2016
- Discussions on Market Price Survey for 2017 Revision Likely to Begin in March, Conclusion Expected in June
January 19, 2016
- Abe Vows to Work All-Out to Supervise Drug Manufacturers after Kaketsuken Oversight
January 19, 2016
- ICH-S9 Guideline to Apply to Non-Clinical Studies for “Serious Malignancies”
January 19, 2016
- New ICH Trial Guidelines to Embrace “Pooled Populations,” but PMDA Unlikely to Accept Zero Japanese
January 18, 2016
- MHLW Taskforce on Vaccines, Blood Products Kicks Off Discussions
January 15, 2016
- Research-Driven Makers Should Find Another Biz Model If They Can’t Innovate: Top Bureaucrat
January 15, 2016
- Fulminant Hepatitis to Be Added to List of Significant Adverse Reactions to Amlodipine Products
January 14, 2016
- AMED, US NIH Ink Memorandum of Cooperation for Orphan Diseases, Cancer
January 13, 2016
- Kaketsuken Ordered Record 110-Day Suspension, Shiozaki Says He Won’t Allow It to Remain As-Is
January 12, 2016
- Re-Pricing Rule for “Huge-Seller” Drugs Necessary Compromise to Protect Universal Healthcare While Promoting Innovation: Health Minister
January 12, 2016
- Kaketsuken Faces 110-Day Biz Suspension, Urged to Dissolve as Legal Entity
January 8, 2016
- Careful Administration Re-stressed for Inavir, Relenza in Dairy-Sensitive Patients: Safety Bulletin
January 8, 2016
- Editor’s Pick: Five Healthcare Policy News Headlines for December 2015
January 8, 2016
- Shipment of Some Lots of Kaketsuken’s Kenketsu Globulin OK’ed
January 7, 2016
- Health Policy Bureau’s FY2016 Draft Budget Earmarks 5.7 Billion Yen to Promote Clinical Research
January 5, 2016
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