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 Issues Notification to Redefine “Three Officer System” at Drug Makers
June 29, 2017
- Yamamoto Chemical Slapped with 22-Day Biz Suspension
June 29, 2017
- JMA’s Nakagawa Wants Clear Definitions for Original Drug, LLP, AG, Gx: Chuikyo
June 29, 2017
- “CEA” Scheme to Be Initially Introduced for Post-Listing Price Adjustment, Targeting Innovative Products with Big Market: Chuikyo
June 29, 2017
- Chuikyo Agrees to “Reward Innovation More” when Using Cost Calculation Pricing Method
June 29, 2017
- PMDA’s Review-Related Ordinary Loss Nearly Doubled in FY2016
June 28, 2017
- MHLW Calls for Drafting Guidelines on Polypharmacy in the Elderly
June 27, 2017
- 6 APIs Added to List of “Switch OTC” Candidates: MHLW
June 26, 2017
- MHLW Redefines Drug Makers’ 3 Key Officer System
June 26, 2017
- Boxed Warning to Be Erased from Label of Pfizer Smoking Cessation Aid Champix
June 26, 2017
- Emergency Stockpile of Anti-Influenza Drugs to Be Reduced to Enough for 47.7 Million People
June 26, 2017
- 670 Codeine, Tramadol Medicines to Be Contraindicated for Kids under 12
June 23, 2017
- Wakayama Substance Supplier Mixed in China-Made Ingredient; MHLW Sees No Safety Concerns
June 23, 2017
- 3 Independent Administrative Agencies Will Have Access to Research Funding from Outside Initial Budgets
June 23, 2017
- Pharmaceuticals, Medical Devices Unlikely to Be Focus of Japan-EU EPA
June 22, 2017
- Draft Guideline on Lifecycle Management Reaches Agreement at ICH Meeting in Montreal
June 22, 2017
- JMA Plans Chuikyo Rep Reshuffle, Nakagawa Likely to Bow Out
June 21, 2017
- PMDA Beats FY2016 Review Time Targets
June 16, 2017
- CDISC-Based Electronic Submissions for 24 Products in FY2016: PMDA
June 16, 2017
- 15.3 Billion Yen to Be Allocated to 30 Projects to Promote R&D in Field of Healthcare
June 16, 2017
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