REGULATORY
MHLW Sorts Out Schemes for Humanitarian Trials, Patient-Initiated Mixed Care
The Ministry of Health, Labor and Welfare (MHLW) issued a notification to prefectural authorities on March 4, clarifying the relation between two new schemes - the Japan version of compassionate use, dubbed “humanitarian trials,” and the so-called “patient-initiated mixed care.”…
To read the full story
Related Article
- MHLW Council to Draft Negotiation Rules on Supply of Unapproved Drugs under Patient-Initiated Mix Care Scheme
March 18, 2019
- Japan Compassionate Use Gets Underway Covering Sakigake-Requested Products, Orphans
January 26, 2016
- Chuikyo Approves Draft Framework for Patient-Initiated Mixed Care; Will Establish Evaluation Council by Next Spring
October 2, 2015
- Patient-Initiated Mixed Care Used Only When Compassionate Access Can’t Be Applied: Minister
April 28, 2015
REGULATORY
- MOF Pushes for Full-Scale FY2027 Off-Year Drug Price Revision Ahead of “Spring” Proposal
April 28, 2026
- Japan Panel Backs Boehringer’s IPF Drug, Moderna COVID Vaccine
April 28, 2026
- Japan Allows Flexibility on Pharmacopoeia Test Differences in Supply Crunch
April 28, 2026
- Zepbound in Line for OSA Approval after Key Panel Nod
April 27, 2026
- LDP Team Urges Patent-Period Price Maintenance, CEA Review in Growth Strategy Proposal
April 27, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





