REGULATORY
MHLW Revises GCP Ordinance, Pushes Clinical Trials with Simple Contract Procedures
In response to the partial amendment of the Pharmaceutical Affairs Law (PAL) enforcement regulations and the ministerial ordinance on Good Clinical Practice (GCP), announced officially on December 28, the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labor…
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REGULATORY
- Unpacking “MFN”: Japan Listed as Reference Country in US Pricing Models
April 16, 2026
- MHLW to Set Criteria for Exemptions under OTC-Like Drug Charge Scheme
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- MHLW Taps Kawabata to Lead Drug Discovery Support Office
April 15, 2026
- MHLW Reviewing EMIS Data on Petro-Product Supply to Medical Institutions
April 15, 2026
- Japan Panel to Review Ferring Gene Therapy, Fujifilm Cell Product on April 20
April 14, 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…





