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REGULATORY
- Upcoming Act on Pharmaceuticals and Medical Devices to Require “Latest Information in Package Inserts”: PFSB
August 11, 2014
- MHLW Orders Revision of Package Insert for Remicade
August 8, 2014
- Is Legal Regulation Necessary? Clinical Research at Turning Point 3: Dr Yamamoto of SCJ
August 8, 2014
- Govt to Enhance Support to Boost Pharma Sector’s Competitiveness: Health Policy Bureau Head
August 7, 2014
- Health Insurance Bureau Chief Says Discussions on Accurate Market Prices and Frequency of NHI Price Revisions Important
August 7, 2014
- MHLW Issues Notification Calling for Compliance with GVP Ministerial Ordinance
August 7, 2014
- MHLW to Survey Rate of Generic Drug Use Under High-Cost Healthcare System; Regulatory Reform Council Concerned that System Provides Little Incentive to Use Generics
August 6, 2014
- PFSB’s Budget Request for FY2015 Will Seek Funding to Strengthen Operations at PMDA: Director-General
August 6, 2014
- MHLW to Remind Drug Makers of Proper ADR Reporting in Wake of Administrative Improvement Order to Novartis
August 4, 2014
- MHLW to Fund Research Aimed at Obtaining Additional Indications for Intractable and Orphan Diseases for Existing Drugs
August 4, 2014
- PAFSC First Committee Backs Approval of MSD’s Insomnia Treatment
August 4, 2014
- JPMA to Examine Clinical Trial Costs
August 1, 2014
- Improvement Order Issued to Novartis over Delayed ADR Reporting
August 1, 2014
- Government to Increase Review Fee for New Generic Drugs from 630,000 Yen to 940,000 Yen
August 1, 2014
- JPA’s Abe Makes Chuikyo Debut, Says No to Annual Drug Price Revisions
July 31, 2014
- Regulatory Review Trend in Japan Signals Pharmas’ Shift to Cancer Drugs: Jiho Tally
July 30, 2014
- MHLW Bulletin Notifies of Revised Package Inserts Warning Concurrent Use of ARBs, ACE Inhibitors
July 30, 2014
- NIBIO Initiates Support for Applied Research on 15 Promising Drug Seeds with Goal of First Licensing Agreement by FY2015
July 30, 2014
- MHLW to Review Criteria for Clinical Research Core Hospitals by April
July 29, 2014
- Revised PAL Mandating Submission of Package Inserts to Minister Will Take Effect on Nov 25
July 29, 2014
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