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REGULATORY
- MHLW Plans to Establish Ethics Committee Certification System to Improve the Quality of Clinical Research
September 18, 2013
- Diovan Scandal Undermined National Interests, Health Ministry Official Says
September 18, 2013
- Director Jo of EAD Urges Drug Makers to Go on the Offensive
September 18, 2013
- PAFSC Second Committee Supports Hepatitis C Treatment Simeprevir, Plasma Fraction Product Hizentra
September 17, 2013
- 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
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
