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REGULATORY
- Any CEA-Based Price Adjustment Must Be Limited to Premium Rates: 3 Pharma Groups
October 11, 2017
- MHLW to Issue Basic Guide to PMS for Conditional Early Approval: Drug Review Chief
October 11, 2017
- Japan Needs “Quick and Low-Cost” R&D Setup: Top MD Bureaucrat
October 10, 2017
- MHLW’s JETRO NY Post Ended Because There Was No Request: Govt
October 10, 2017
- Health Minister Questions How to Gauge Success in Outcome-Based CAR-T Pricing in Japan
October 10, 2017
- Revised Ministerial Ordinance on Preventing Distribution of Counterfeit Drugs to Take Effect Jan. 31
October 10, 2017
- 3rd Round of Sakigake Invitations Begin
October 6, 2017
- Social Security Council Members Reiterate Opposition to Reference Pricing for LLPs, or LLP-Gx Uniform Prices
October 6, 2017
- MHLW to Place Priority on “Mutual Understanding” with Industry: Economic Affairs Chief
October 6, 2017
- “Pediatric Treatment”, “Innovation” Excluded from Ethical/Social Factors in Pilot CEA Program: Chuikyo
October 5, 2017
- MHLW Drops 5-Scale CEA Rating, Pitches Slope-Like Price Adjustment Model: Chuikyo
October 5, 2017
- Chuikyo Mulls over Scope of CEA-Based Price Adjustments - Premium Portion or Total NHI Price?
October 5, 2017
- Payers Oppose Price Hikes based on CEA at 1st Joint Meeting: Chuikyo
October 5, 2017
- Chuikyo Members Object to Extension of Prescription Limit for Injectable Ethical Narcotic
October 5, 2017
- MHLW Wants to Introduce Conditional Early Approval System This Month: Minister
October 3, 2017
- MHLW Presents Four Patterns for Review of Clinical Research That Falls Under “Specified Clinical Research” Category
October 2, 2017
- Drug Makers to Be Required to Disclose Donations, Lecture Fees, and Writing Fees Tied to “Specified Clinical Research”
October 2, 2017
- MHLW to Compile Guidelines for Proper Drug Promotion Activities
October 2, 2017
- (Update) Bayer Told to Improve Practice over ADR Reporting Delays, Gets “Verbal Guidance” for Xarelto Survey Fuss
October 2, 2017
- MHLW Unveils Planned Framework for Conditional Early Approval Scheme
September 29, 2017
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