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REGULATORY
- 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- Development Request Withdrawn for Mitoxantrone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
- MIPO to Begin Preparing for Drug Discovery Support Organization
December 26, 2011
- 0.9% Additional Price Cut for Long-Listed Drugs, Compensating Upward Revision of Nursing Fee: Minister Negotiation
December 22, 2011
- PAC Recommends Approval for Products Recommended by PAFSC’s Committee on Drugs
December 22, 2011
- CSIMC Approves Additional Price Reduction for Long-listed Drugs Next Year
December 22, 2011
- Sanofi-aventis Selected for METI Subsidy to Build Regional HQ in Japan
December 22, 2011
- Price Cut Negotiations for Long-Listed Products Between MOF, Health Ministers “Parallel”
December 21, 2011
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