Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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REGULATORY
- PAFSC’s Second Committee Recommends Approval for Bronchial Asthma Treatment Flutiform, Others
July 29, 2013
- Half of All Drugs, Add’l Indications Approved from FY2009 to FY2012 Underwent Clinical Trials at NHO Hospitals
July 29, 2013
- MHLW-MEXT Joint Committee Agrees to Require Researchers to Store Clinical Research Data for Long Periods
July 26, 2013
- MHLW Might Submit Bill on Online OTC Sales to Extraordinary Diet Session: PFSB Head
July 25, 2013
- CSIMC Approves Questionnaire to Determine Impact of FY2012 Medical Fee Revision on Generic Drug Use
July 25, 2013
- Diovan Study Committee to Hold 1st Meeting in Early August: Minister
July 24, 2013
- Stivarga Effectively 1st Drug Offered under Japan’s “Compassionate Use” System
July 23, 2013
- Pilot Program for Japan-Version “Compassionate Use” System to Begin at National Cancer Center
July 23, 2013
- 1st Committee to Discuss Approval of New Products Including Janssen’s Extended Release Schizophrenia Treatment
July 23, 2013
- MHLW OKs AMD Clinical Research Using iPS Cells
July 22, 2013
- MHLW Mulls “Ultra-Orphan” Drug System; Designation Might Become Possible with Pre-Clinical, Healthy Subject Data
July 22, 2013
- US Aims for Lifting of Ban on Mixed Care: Prof. Murakami of Yamagata University
July 22, 2013
- South Korean MOHW Officials Announce Roadmap for South Korea to Become No. 7 Worldwide in New Drug Development by 2020
July 19, 2013
- CSIMC Begins Full-Scale Discussions on FY2014 NHI Price Revision; Generics as Well as Long-Listed Original Drugs May Face Further Price Cuts
July 19, 2013
- eCTD Progresses to Step 4 at ICH in Brussels
July 18, 2013
- 2nd Committee on Drugs to Discuss Approval for Asthma Treatment Flutiform on July 26
July 17, 2013
- MHLW, US FDA to Exchange Information with a View to Standardizing Review Guidelines for Regenerative Medicines
July 17, 2013
- Health Ministry to Set Up Committee on Diovan Studies, Compile Preventive Measures for Clinical Data Manipulation
July 16, 2013
- MHLW Presses Kyoto Prefectural University of Medicine to Carry on Diovan Probe
July 16, 2013
- Health Ministry Requests Revisions of Precautions for Invega Tablets, Other Drugs
July 12, 2013
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The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…