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
- 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
- “Drugs for Specific Use” under Amended PMD Law Covers Pediatric Use, Antimicrobial Resistance: Official
March 22, 2019
- LDP Lawmakers Not So Positive about Reflecting Societal Values to Drug Prices; They Don’t Know How
March 22, 2019
- MHLW Orders Label Revisions for Takecab, Clozapine and More
March 20, 2019
- Japan Cabinet OKs Bill to Amend PMD Law
March 20, 2019
- Generic Drug Use Rates Particularly Low for Insurance Societies of Research-Driven Drug Makers: MHLW
March 20, 2019
- MHLW Council Rejects OTC Switches of 4 Alzheimer’s Drugs
March 19, 2019
- MHLW Council Recommends OTC Switch of Polycarbophil Calcium
March 19, 2019
- PMD Bill Clears LDP Review, Cabinet OK Slated for March 19
March 18, 2019
- MHLW Council to Draft Negotiation Rules on Supply of Unapproved Drugs under Patient-Initiated Mix Care Scheme
March 18, 2019
- Japan Cabinet OKs PMDA Review Fee Rise from April 1
March 18, 2019
- MHLW Seeks Opposition Party Understanding on Removal of Officer Change Order Provision from Amendment Bill for PMD Law
March 15, 2019
- MHLW Grants Orphan Status to Cx601, Takeda’s 1st Cell Therapy
March 15, 2019
- MHLW to Draw Up Guidelines on Registry Data Use for Submissions: Clinical Innovation Network Initiative
March 15, 2019
- HSC Committee Continues to Discuss Reorganizing Core Clinical Research Hospitals
March 15, 2019
- Xofluza-Resistant Viruses Detected in Xofluza-Naïve Patients: NIID
March 15, 2019
- MHLW’s Panel Compiles Interim Paper for Promotion of Clinical Research, Trials
March 14, 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…