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REGULATORY
- MHLW to End Manufacturing Record Inspection for Kaketsuken’s Plasma Fraction Products
June 1, 2018
- MHLW Positive on Enshrining Conditional Approval, Sakigake Schemes into Law: Official
May 31, 2018
- Japan’s First Biosimilars for Enbrel, Herceptin Added to NHI Price List
May 30, 2018
- Honebuto Policy Won’t Include Numerical Target for Social Security Costs
May 29, 2018
- Takeda’s Entyvio Up for MHLW Panel Review on June 8
May 28, 2018
- MHLW Grants Orphan Status to Vyndaqel, Burosumab
May 28, 2018
- MHLW OKs Add’l Indications for Xeljanz, Botox, Nucala
May 28, 2018
- MOF Pitching 2-Step Drug Price Tweaks in 2019 Tax Hike Year
May 25, 2018
- MHLW Flu Panel Approves Plan to Switch to H7N9 Strain for Pre-Pandemic Flu Vaccine
May 25, 2018
- Chuikyo Approves Insurance Reimbursement for 3 Medical Devices, with Listing Scheduled for June
May 25, 2018
- Chuikyo Tightens Physician Fee Rules for Self-Injections, Biosimilars Up for Individual Review
May 25, 2018
- Lynparza’s Breast Cancer Use, Chugai’s Obinutuzumab Clear MHLW Panel
May 24, 2018
- PMDA, FDA Team Up to Help Developing Countries to Facilitate Pediatric Drug Development
May 24, 2018
- Revisit Automatic Coverage for New Drugs, Discuss Mandatory CEA: MOF Panel Proposal
May 24, 2018
- No Specific Social Security Cost Target Discussed at CEFP, All Eyes on How to Handle FY2019-FY2021 Elderly Trough
May 22, 2018
- MHLW Presents Schedule for Discussions on Inclusion of 6 Vaccines in Public Vaccination Programs
May 21, 2018
- MHLW-MOF Negotiations Heating Up over Curtailment of Social Security Costs
May 18, 2018
- MHLW Finds 67 Suspected Violations in Sales Reps’ Advertising Activities; Cites Need for Official Reporting System
May 18, 2018
- Working Group Discussions Underway to Address Technical Issues for CEA before Confirmatory Analyses for 7 Products
May 18, 2018
- Warning against Use in Teenagers Should Be Removed from Tamiflu’s Package Insert: MHLW Panel
May 18, 2018
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