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
- PMDA to Expand Consultation Services for Clinical Trials Initiated by Academia
November 12, 2014
- Blue, Yellow Letters to Cover Regenerative Medicines
November 11, 2014
- MHLW Mulls Creating Rules under Law for Patient-Initiated Mixed-Care System
November 11, 2014
- PAFSC First Committee to Discuss Takeda’s Vonoprazan on Nov. 21
November 11, 2014
- US FDA Withdraws Tentative Approvals for 2 Generic Drugs of Ranbaxy
November 11, 2014
- 5 Experts Likely to Review Regenerative Medicines for Expedited Senshin-Iryo Scheme
November 10, 2014
- Health Ministry Panel Includes Legal Regulations for Clinical Research in Draft Outline
November 10, 2014
- Chuikyo OKs Patient-Initiated Mixed-Care System, Use of Investigational Drugs for Non-Enrollable Patients
November 7, 2014
- Chuikyo Approves Insurance Coverage for Regenerative Medicine Products upon Conditional Approval
November 7, 2014
- PMDA Assessing Reminyl for Risk of Acute Generalized Exanthematous Pustulosis
November 6, 2014
- MHLW Issues Notifications on Drug/Medical Device Combination Products
November 6, 2014
- Sept. Drug Price Settlement Rate at 92.6% as Big Hospitals, Pharmacies Take Quantum Leap
November 6, 2014
- Editor’s Pick: Five Healthcare News Headlines for October 20 - October 31
November 5, 2014
- PMDA Establishes Office of Generic Drugs to Expedite Review and Consultation for Generic Drugs
November 4, 2014
- Cabinet OKs Appointment of Keio Prof as Japan NIH Head
October 31, 2014
- MHLW to Issue Notification with Survey Form on Adverse Reactions to HPV Vaccines
October 31, 2014
- Lantus Biosimilars Likely to Be OKed by Year-End: First Committee
October 30, 2014
- Welfare Recipients Should Pay Difference between Generic and Branded Drug Prices: MOF
October 29, 2014
- Health Ministry Shares Views on PI Studies for Japanese Patients
October 29, 2014
- Risk of Fulminant Hepatitis Added to Lyrica Package Insert: MHLW
October 29, 2014
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Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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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…