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
- 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
- Hyperthyroidism Added to Serious ADR Section of Flolan’s Package Insert
December 28, 2011
- MHLW Commission Says Joint Purchasing an Advantage to Integration of National, Rosai Hospitals
December 28, 2011
- Additional NHI Price Cuts Decided: ¥22.5 Billion for Long-Listed Drugs, ¥2.5 Billion for Generics
December 27, 2011
- PFSB Draft Budget Includes ¥2.1 Bil. to Improve Review, Safety Measures
December 27, 2011
- Reevaluation Recommended for Lysozyme, Pronase
December 26, 2011
- Tougher Restrictions on Reimbursement of Vitamins to Cut ¥15 Bil. from Med. Expenditure
December 26, 2011
- Development Request Withdrawn for Mitoxantrone
December 26, 2011
- Application Based on Data from Public Domain Recommended for 6 APIs Including Amlodipine
December 26, 2011
- ¥25 Bil. to Be Saved through Add’l NHI Price Cuts for Both Long-listed, Generic Drugs in FY2012: MHLW
December 26, 2011
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