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
- MHLW Informally Notifies Drug Makers of Post-Oct. 1 NHI Prices
April 9, 2019
- Sakigake Status Granted to Takeda’s Narcolepsy Med, Ninlaro, Daiichi Sankyo’s Valemetostat and More
April 9, 2019
- Japan’s 1st Avastin Biosimilar Could Get Listing as Early as November; Lilly’s EGFR Up for MHLW Panel Review
April 8, 2019
- Epadel OTC to Be Reclassified as “Class 1” Category under Stricter Rules on Sales: MHLW Panel
April 5, 2019
- New Detailing Guidelines Take Effect on April 1; Q&A on Information Supply on Unapproved Drugs/Indications Issued
April 2, 2019
- MHLW Reveals Details of New Withdrawal Rules for Off-Patent Branded Drugs
April 1, 2019
- PMDA Conducting Risk Review for Suglat, Forxiga, Opdivo, and More
April 1, 2019
- MHLW Orders Shift from “Relative Contraindications” to “Contraindications” in Labels of Hypnotics, Antibiotics and More
April 1, 2019
- PMDA Reprimands 3 Senior Officials after Employee Dismissal
April 1, 2019
- Kymriah, Collategene to Follow Drug Listing Pathway: Chuikyo
March 28, 2019
- Chuikyo Reps Want Early Debate for 2020 Drug Price Revision; Polypharmacy, Formulary Also on Agenda
March 28, 2019
- Chuikyo OKs Details of Cost-Effectiveness Assessment Scheme
March 28, 2019
- Chuikyo OKs 70% Pricing for Nesp Biosame; New Rules Up for FY2020 Reform Debate
March 28, 2019
- Opdivo Up for Yet Another Re-Pricing after CEA Confirmatory Analysis, but New Price Undisclosed
March 28, 2019
- National Cancer Center’s Fujiwara Named New PMDA Chief
March 27, 2019
- Gilead’s HIV Triplet Biktarvy to Join NHI Price List on April 3
March 27, 2019
- MHLW Approves Vyvanse, Biktarvy, Trelegy, Vyndaqel, Dupixent Asthma Use and More
March 27, 2019
- Japan Clears Second Enbrel Biosimilars
March 27, 2019
- PMDA’s Preventative Measures for Document Losses Focus on Traceability, Digitalizing
March 27, 2019
- Japan’s Direct Patient ADR Reporting System Now in Full Operation
March 27, 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…