Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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REGULATORY
- Gist of FY2014 NHI Price Revision
December 26, 2013
- Health Ministry to Request Hospitals to Inspect Clinical Studies Initiated between FY2000 and 2008
December 26, 2013
- Chuikyo Approves Outline for NHI Price Reform Including New Rule for Long-Listed Drugs; Trial of Premium for New Drug Development to Continue
December 26, 2013
- Regulatory Reform Council Gives Directions for Expansion of Special Scheme for Mixed Healthcare, Yet No Concrete Plan
December 26, 2013
- Health Ministry Committee Decides Details of Drug Safety Evaluation after Rx-to-OTC Switches
December 26, 2013
- FY2014 Budget: 95.4 Billion Yen for Japan NIH, Development of Novel Drugs
December 25, 2013
- Government to Allocate 8,696 Million Yen in FY2014 Budget for Faster Drug Review, Pharma Business Revitalization
December 25, 2013
- FY2014 NHI Price Revision Down 5.7% Excluding Tax Adjustments
December 24, 2013
- MHLW Will Level Charges against Novartis, If Necessary: Minister
December 24, 2013
- Premium for Innovativeness or Usefulness (I) Set as Prerequisite for 10% “Precursor Premium”
December 20, 2013
- Generic Share Fails to Meet FY2012 Target but Reaches 47% in New Calculation Method
December 20, 2013
- Chuikyo’s DPC Subcommittee Continues to Support Original Proposal on Generic Drug Index; Will Report Accordingly at Upcoming General Meeting
December 20, 2013
- PhRMA Japan Head, Other Observers Invited for Comments for First Time at Health Ministry Vaccination Panel
December 20, 2013
- Vaccine Dose Intervals to Become More Flexible Starting Next April
December 20, 2013
- Plan to “Institutionalize” Key Premium Ditched for FY2014 Revision; Status Quo to Remain
December 19, 2013
- Chuikyo Subcommittee Agrees on 60% Rule for First Generic Prices, 70% for Biosimilars
December 19, 2013
- Off-Patent Drugs to Get Continuous Price Cuts Until 60% Generic Share Reached
December 19, 2013
- “COI Management” to Be Specified in Unified Ethics Code for Epidemiological, Clinical Research
December 18, 2013
- Japan NIH to Be Staffed with 100-Plus Employees from 6 Govt Organizations
December 18, 2013
- MHLW Boots Up Project Team to Spur Clinical Application of Novel Drugs; Paper Due Out in April
December 17, 2013
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