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
- MHLW to Introduce E2B (R3) Format in April 2016
September 24, 2013
- FTC’s Legal Intervention in Diovan Issue Possible, but Only with New Facts: Lawyer
September 20, 2013
- MHLW Requests Revision of Package Inserts for Losartan, Celecoxib, 9 Other Drugs
September 19, 2013
- MHLW Plans to Establish Ethics Committee Certification System to Improve the Quality of Clinical Research
September 18, 2013
- Diovan Scandal Undermined National Interests, Health Ministry Official Says
September 18, 2013
- Director Jo of EAD Urges Drug Makers to Go on the Offensive
September 18, 2013
- PAFSC Second Committee Supports Hepatitis C Treatment Simeprevir, Plasma Fraction Product Hizentra
September 17, 2013
- Intussusception to Be Added to Adverse Reaction Section of Package Insert of RotaTeq
September 17, 2013
- Regulatory Reform Council Puts Off Concluding Discussion on Use of Clinical Intervention Study Data for Drug Applications
September 13, 2013
- Ms Ishii of LDP Calls for Permanent Extension of R&D Tax Credit for High-Level Investment
September 13, 2013
- MHLW Lifts Certified Oncologist Requirement for Tarceva
September 12, 2013
- Medical Expenditure for Dispensing Totaled 6,590.2 Billion Yen in FY2012; Generic Drug Ratio 28.7%
September 12, 2013
- Diovan Panel Poised to Conduct Hearings with Ex-Novartis Employee, Authors
September 11, 2013
- Education Ministry Requests 950 Million Yen Budget for Promoting Generic Use at National University Hospitals
September 11, 2013
- PMDA Eyes Mandatory Electronic Filings for NDA Clinical Trial Data from FY2016
September 11, 2013
- Cabinet Secretariat’s TPP Headquarters Briefs Industry Organizations on 19th Round of TPP Talks
September 11, 2013
- Health Ministry to Introduce New System for Online Import and Export Declarations as Early as Next Autumn
September 9, 2013
- Council on Regulatory Reform’s Working Group to Present Recommendations by Year-End for More Effective Use of (Pre-Trial) Clinical Study Data for Earlier Marketing Approval
September 9, 2013
- MHLW Sets to Tap into Advanced Healthcare Scheme to Shed Drug Lag for Anticancer Agents
September 5, 2013
- CSIMC’s Cost-Effective Assessment Subcommittee Fails to Forge Consensus; Draft Interim Report Simply Lists Pros and Cons
September 5, 2013
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