Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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REGULATORY
- Drug Price Cuts to Save 174.9 Billion Yen in State Coffers: MOF
December 25, 2015
- FY2016 Draft Budget Includes 82.5 Bil. Yen to Promote Creation of Innovative New Drugs and Medical Devices
December 25, 2015
- AMED-Led Screening Consortium Gets Underway with 22 Japanese Makers
December 24, 2015
- Plavix, 15 Other Brands to Lose Premiums on Generic, Biosimilar Entries; Re-Pricing Could Deal Another Blow
December 24, 2015
- MHLW OKs Add’l Indications for Remicade, Other Drugs
December 22, 2015
- Drug Prices to Be Pared 7.8% If Re-Pricing, Z2, Generic Price Cuts Included
December 22, 2015
- 3.6 Billion Yen in FY2015 Extra Budget to Go to IFN-Free Hep C Therapies
December 21, 2015
- Japan, India Sign Memorandum for Regulatory Affairs
December 21, 2015
- MHLW Grants Orphan Drug Designation for Sakigake Product Sirolimus, Others
December 21, 2015
- Govt to Shed 28 Bil. Yen via Huge Seller Drugs, 20 Bil. Yen via Existing Re-Pricing Rule; Physicians to Win “Plus” Revision
December 21, 2015
- Shipments of Kaketsuken’s Hep B Vaccine Likely to Resume Early Next Year
December 18, 2015
- MHLW to Carefully Discuss Cost Effectiveness of Prevenar 13 for Its Elderly Use under National Program
December 18, 2015
- ICH Reaches Agreement to Treat Subjects with Similar Ethnic Factors as Single Populations Regardless of Nationality
December 18, 2015
- PMDA Beating Targets for Overall Review Time in FY2015
December 18, 2015
- Chuikyo Approves Plan to Introduce Cost-Effective Assessments on Trial Basis; Selection of Products to Begin Next April
December 17, 2015
- Premium for Sakigake Products Clears Chuikyo Subcommittee
December 17, 2015
- Survey Finds Unexpectedly Low Market Prices for Injectable Generics; Industry to Accept 50% Rule
December 17, 2015
- Chuikyo Subcommittee OKs Outline of FY2016 Drug Pricing Reform, Rollout of “Huge Seller” Re-Pricing
December 17, 2015
- PMDA Plans to Increase Inspection Staff in Response to Kaketsuken Scandal
December 17, 2015
- Japan to Draw Up Action Plan on Drug Resistance: Health Minister
December 16, 2015
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Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…