Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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REGULATORY
- Reimbursement Policies for CAR-T, Other Pricey Drugs Might Come Up for Discussion on Oct. 10
October 5, 2018
- New Health Minister Stresses Needs for “Reasonable Drug Pricing”
October 4, 2018
- PM Abe Keen on Intensive 3-Year Reform for “All-Generation” Social Security, Taps Motegi to Lead Initiative
October 3, 2018
- Industry Rep Vows to Abide by Drug Detailing Guidelines
October 2, 2018
- Takumi Nemoto Picked as New Health Minister
October 2, 2018
- Council Approves Draft Revision of “Basic Policy on Blood Products”
October 2, 2018
- MHLW Proposes “Institutionalization” of Conditional Approval, Sakigake Schemes
October 1, 2018
- MHLW Sees October 2019 “Natural” Timing for Tax Hike-Linked Price Revision, but Likely to Moot Other Options Too
September 27, 2018
- MHLW Issues Guidelines on Detailing Activities by Sales Reps; to Take Effect Next April
September 27, 2018
- ASKA’s Generic Valsartan Might Cause Cancer in 1 in 15,000-30,000 Patients: MHLW
September 27, 2018
- Healthcare Spending a Record 42.2 Trillion Yen in FY2017, Drug Costs Up 2.9%: MHLW
September 26, 2018
- Pfizer’s Lorlatinib Gets 1st Conditional OK; MHLW Approves Astellas AML Drug and More
September 25, 2018
- MHLW Panel Members Share Views on One Key Topic toward PMD Law Amendment; Next Meeting Scheduled Soon: Official
September 25, 2018
- Recordati Succeeds Carbaglu Orphan Drug Designation from Pola Pharma
September 20, 2018
- MHLW Orders Package Insert Revision for Xofigo, Warning of Increased Risk of Death, Bone Fracture with 3-Drug Combination
September 20, 2018
- Pfizer to Use MID-NET Database for Ibrance PMS
September 19, 2018
- Second Applicant from Pharma Companies to Use MID-NET: PMDA
September 19, 2018
- Alexion’s PNH Therapy Ravulizumab, Two other APIs Bag Orphan Drug Designations
September 19, 2018
- MHLW Drug Pricing Official Calls on Industry to Present Specific Proposal on PMP
September 19, 2018
- MHLW to Launch Mock Review Project to Up Standards of “Certified IRBs” under Clinical Research Law: Official
September 14, 2018
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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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…