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
- NHI-Market Price Gap of 8.8% Reported to Chuikyo; Generic Share at 56.2% in September
December 7, 2015
- MHLW Calls for 50% Pricing Rule for First Generics, 40% Rule for 10-Plus Oral Generics
December 4, 2015
- New HTA Scheme Should Only Cover Big-Selling Products Given Big Premiums: JPMA Chief
December 4, 2015
- Chuikyo Subcommittee Agrees on Scope of “Essential Drugs”; Trial Run of Innovation Premium to Continue
December 4, 2015
- Chuikyo Basically OKs 2-Tiered Re-Pricing for Huge Seller Drugs; Sovaldi Almost Certain to Face Cut
December 3, 2015
- Probe Finds Kaketsuken’s GMP Violations “Extremely Malicious”, MHLW to Impose Penalty
December 3, 2015
- NHI-Market Price Gap at 8.8%, 6.8% Price Cut Expected in FY2016 Revision
December 3, 2015
- Generic Replacement Rate Applied to Z2 Rule to Be Hiked 10%
December 3, 2015
- Revamped Sakigake Pricing Premium to Grant Maximum Premium Rate of 20%: Chuikyo Subcommittee
December 3, 2015
- Interstitial Pneumonia Added to ADR List for Daklinza, Sunvepra
December 2, 2015
- MHLW Discussing Use of Disease Registry as Substitute for Control Groups; Could Be “One Means of Evaluation” in Trials for Rare Diseases
December 2, 2015
- MHLW Study Group to Survey Unvaccinated Teens to Resolve HPV Issues
December 1, 2015
- PAFSC’s 2nd Committee Backs Lung Cancer Indication for Opdivo
December 1, 2015
- Development of Orphan Drugs Will Require Global Perspective: MHLW Official
December 1, 2015
- PAFSC 1st Committee Gives Nod to Japan’s First PCSK9 Inhibitor
November 30, 2015
- Evaluation of Efficacy Was Challenging in Sakigake Pick, Designating All Qualified Drugs Desirable: MHLW Official
November 27, 2015
- New Dosage Form of Ciproxan, Other Products with Minor Changes to Join NHI Price List on Nov. 28
November 27, 2015
- MHLW Allows Shipment of Kaketsuken DTP-IPV Vaccine
November 27, 2015
- Drug Pricing Debate to Culminate in December; Abraxane, Zosyn Major Candidates for Market Expansion Re-Pricing
November 26, 2015
- Add Type 1 Diabetes to Opdivo Label: MHLW
November 26, 2015
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