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
- Dismissal Order Provision Erased from PMD Law Amendment Bill
March 14, 2019
- MHLW Calls for Cooperation in Genomic Research on Drug-Induced Muscle Disorders
March 14, 2019
- MHLW to Promote Master Protocol Trials to Boost Efficiency in New Drug Development
March 14, 2019
- MHLW Likely to Tweak PMD Law Amendment Bill as Lawmaker Frowns on Order to Change Pharmaceutical Affairs Officer
March 13, 2019
- MHLW Panel Approves Shift from “Relative Contraindications” to “Contraindications” for 5 Drugs/Drug Groups
March 13, 2019
- Detailing Guidelines Casting Clouds over Drug Maker-Sponsored Press Seminars?
March 12, 2019
- Japan Issues 1st Guidance on Cancer Immunotherapy Development
March 11, 2019
- Govt to Ponder Appropriate Ways to Offer Off-Label Info to Patients
March 11, 2019
- LDP Wraps Up Review on Bill to Amend PMD Law; Cabinet OK Eyed in Mid-March
March 8, 2019
- LDP Panels Approve Proposal to Promote Regulatory Harmonization, Improve Access in Asia
March 8, 2019
- Chuikyo Approves Discussion Timeline for FY2020 Reimbursement Reform; Drug Pricing Debates Expected from June
March 7, 2019
- MHLW Grants Orphan Status to Adcetris, Evocalcet and More
March 6, 2019
- PMDA Sacks Employee for Doing Side Business with Companies with COI
March 5, 2019
- Xofluza Ordered to Add Hemorrhage Risk to Its Label
March 4, 2019
- Tagrisso Label Notes Previous Opdivo Use as Risk Factor for ILD
March 1, 2019
- MHLW to Impose Administrative Fines Only on Misleading Ads, Eyes 4.5% Charge: PMD Law
February 28, 2019
- MHLW Bureau Chief Eager to Hold Public-Private Confab towards 2020 Pricing Reform
February 28, 2019
- Kymriah Will Only Have Limited Impact on Health Finances: Minister
February 27, 2019
- Industry Official Prods Govt to Grant PMP to Repositioned Drugs Too
February 26, 2019
- Drug Prices Should Be Lowered in Areas with Needs Met, Like Lifestyle Disease: Prof.
February 26, 2019
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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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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…