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
- 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
- Nesp Biosame Likely to Be Priced at 70% of Originator as Stopgap Measure
March 26, 2019
- JMA Reps Oppose Reclassification of Epadel OTC despite No Serious ADR Reports: MHLW Safety Panel
March 26, 2019
- Patient ADR Reporting System to Go into Full-Scale Operation by March-End
March 26, 2019
- PMDA Chief Kondo to Step Down after 11 Years in Charge
March 25, 2019
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