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
- 45 Face-to-Face Consultation Meetings Provided through PMDA’s Regulatory Strategy Consultation Service as of March 2013
May 30, 2013
- MHLW Reprimands Novartis over Diovan Papers
May 29, 2013
- Report of MOF’s Fiscal System Council Calls for 100% Generic Share Target
May 29, 2013
- PAFSC’s Second Committee Recommends Approval for IV Preparation of Acetaminophen
May 28, 2013
- First Committee Recommends Approval for Third GLP-1 Receptor Agonist Lyxumia, Others
May 27, 2013
- “Strong Guidance Will Be Required” in Diovan Case: Health Minister Tamura
May 27, 2013
- Citations in Guidelines to Be Prerequisite for Health Coverage of Off-Label Drugs under 1980 Notification
May 24, 2013
- New Rules to Promote Generic Drug Use by Welfare Recipients to Take Effect This Year
May 23, 2013
- MOF Official Expresses Caution on Perpetuation of New Drug Premium, Citing “Need for Continual Verification”
May 22, 2013
- MHLW Orders Marketing Authorization Holders of Careram/Kolbet to Issue a “Blue Letter”
May 21, 2013
- PM Abe Indicates that Next Fiscal Reform Plan Will Not Include Controls on Growth Rate of Social Security Spending
May 20, 2013
- NIBIO Establishes Center for Innovative Drug Discovery and Development, Appoints Yoichi Kurebayashi as Director
May 20, 2013
- 39 Companies Report Discontinuing Supplies of Generics within 5 Years: MHLW Survey
May 17, 2013
- Government Aims for 60% Generic Drug Share by End of FY2017; Some See Shortcomings in Roadmap
May 17, 2013
- Pharma Execs Call for Perpetuation of Premium at 1st Public-Private Dialogue under PM Abe’s Second Cabinet
May 16, 2013
- CSIMC Approves Listing of 15 New APIs/19 Products Including Pfizer’s Xeljanz with Expected Peak Sales of 59.7 Billion Yen
May 16, 2013
- 1st Committee on New Drugs to Discuss GLP-1 Agonist Lyxumia, Other New Drugs on May 24
May 15, 2013
- PMDA-WEST to Be Launched in Osaka in October to Undertake Consultation Services, GMP Inspections
May 13, 2013
- Generic Drug Makers Make Only about 20% of Bulk Drug Substances Available from Multiple Sources: Dr Muto of JSGM
May 7, 2013
- MHLW Approves 2 Cell Culture-Based New Influenza Vaccines
May 7, 2013
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