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
- Huge Drop in Compliance Rate for “Explanations in Writing” in Sales of Class 1 OTC Drugs: MHLW Undercover Survey
January 20, 2012
- PMDA to Introduce Direct ADR Reporting System for Patients on Trial Basis
January 20, 2012
- Prof. Nakamura of Keio Univ. Sees Orphan Drug Development Strategy as Reason for Revised Re-pricing Policy
January 20, 2012
- EMA Initiates Review of Oral MS Treatment Gilenya Following Reports of Heart Problems
January 20, 2012
- PAFSC’s Second Committee on Drugs to Review Kyowa Kirin’s ATL Treatment on February 1
January 19, 2012
- PMDA to Expand PGx, Biomarker Consultation System
January 19, 2012
- MHLW Considering “Partial Introduction” of Medico-Economic Evaluation in FY2014
January 18, 2012
- No Serious Concerns Observed for 4 Vaccines: MHLW Study Groups
January 17, 2012
- US Industry Opinion Divided on Japan’s Participation in TPP Talks
January 17, 2012
- PAFSC’s First Committee on Drugs to Review Zyprexa for Depression in Bipolar Disorder on January 27
January 16, 2012
- MHLW Proposes New Fee for Medical Management of Treatment-Resistant Schizophrenia
January 16, 2012
- MHLW Director Tawaragi Raises 3 Points, Including Risk Management Planning, as Priority Measures for FY2012
January 13, 2012
- MHLW to Strengthen Support for Ultra-Orphan Drug Development
January 13, 2012
- PFSB Calls for Revision of Package Inserts for 15 Products
January 12, 2012
- MHLW Revises Ministerial Ordinance to Prohibit Dispensing Point Services by Pharmacies
January 12, 2012
- MHLW Issues Administrative Notification on Reexamination Period for 8 Products Approved After Partial Changes
January 11, 2012
- MHLW Issues Notification on Change in Clinical Trial Protocols
January 11, 2012
- Nicotine Patch Products Should Remain Class 1 OTC Drugs: PAFSC Subcommittee
January 11, 2012
- JPO Amends Patent Examination GL to Allow Patent Extension for New Formulations Containing Existing APIs
January 10, 2012
- EC Approves Revised Product Labeling for Actos: Takeda
January 10, 2012
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