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REGULATORY
- Intussusception to Be Added to Adverse Reaction Section of Package Insert of RotaTeq
September 17, 2013
- Regulatory Reform Council Puts Off Concluding Discussion on Use of Clinical Intervention Study Data for Drug Applications
September 13, 2013
- Ms Ishii of LDP Calls for Permanent Extension of R&D Tax Credit for High-Level Investment
September 13, 2013
- MHLW Lifts Certified Oncologist Requirement for Tarceva
September 12, 2013
- Medical Expenditure for Dispensing Totaled 6,590.2 Billion Yen in FY2012; Generic Drug Ratio 28.7%
September 12, 2013
- Diovan Panel Poised to Conduct Hearings with Ex-Novartis Employee, Authors
September 11, 2013
- Education Ministry Requests 950 Million Yen Budget for Promoting Generic Use at National University Hospitals
September 11, 2013
- PMDA Eyes Mandatory Electronic Filings for NDA Clinical Trial Data from FY2016
September 11, 2013
- Cabinet Secretariat’s TPP Headquarters Briefs Industry Organizations on 19th Round of TPP Talks
September 11, 2013
- Health Ministry to Introduce New System for Online Import and Export Declarations as Early as Next Autumn
September 9, 2013
- Council on Regulatory Reform’s Working Group to Present Recommendations by Year-End for More Effective Use of (Pre-Trial) Clinical Study Data for Earlier Marketing Approval
September 9, 2013
- MHLW Sets to Tap into Advanced Healthcare Scheme to Shed Drug Lag for Anticancer Agents
September 5, 2013
- CSIMC’s Cost-Effective Assessment Subcommittee Fails to Forge Consensus; Draft Interim Report Simply Lists Pros and Cons
September 5, 2013
- MHLW’s FY2014 Budget Request Earmarks Funds to Expand Generic Drug Savings Notification Project to All Insurers
September 5, 2013
- Key Govt Council Sets Up 4 Subcommittees; Scraping of Insurance Coverage for OTC-Like Drugs Up for Discussion
September 4, 2013
- PAFSC Second Committee on Drugs to Discuss Hepatitis C Treatment Simeprevir at Meeting on September 13
September 3, 2013
- Diovan Panel Heats Up Over Future Course of Discussions; “Find Out Truth” vs “Identify Structural Flaws”
September 3, 2013
- MHLW Aims to Reduce Medical Expenditure by 1 Trillion Yen by FY2025 through Measures to Promote Generic Drug Use
September 2, 2013
- MHLW Adds Interstitial Pneumonia as Serious Adverse Reaction of Simponi
August 30, 2013
- 8% Sales Tax Will Be Tacked on Drug Market Prices, How It Will Be Shown Not Yet Agreed: MHLW Panel
August 30, 2013
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