Discussions by the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry structure are reaching the last lap. Its final report - a draft of which will be presented later this month - is expected to…
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REGULATORY
- Chuikyo OKs Outline of FY2016 Drug Pricing Reform
December 25, 2015
- 130 Million Yen Earmarked to Boost PMDA Staffers for Accelerating Review: FY2016 Budget
December 25, 2015
- MHLW Looked at Innovativeness, Seriousness of Target Disease to Select Sakigake Products
December 25, 2015
- MHLW Launches Confab to Shore Up Healthcare Startup Sector
December 25, 2015
- 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
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Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…