REGULATORY
Industry Asked for Legislation for Conditional Early Approval and Sakigake Designation Scheme: MHLW Panel
Pharma industry representatives called for legislation for the conditional early approval system and sakigake fast-track designation scheme at a meeting of a health ministry panel on May 9. At a meeting of the Health Sciences Council’s (HSC) subcommittee for regulations…
To read the full story
Related Article
- MHLW Panel Members Share Views on One Key Topic toward PMD Law Amendment; Next Meeting Scheduled Soon: Official
September 25, 2018
- Experts Support Plan to Seize Improperly Earned Revenue as in Diovan Case: HSC
June 8, 2018
- MHLW Positive on Enshrining Conditional Approval, Sakigake Schemes into Law: Official
May 31, 2018
- MHLW Panel Starts Discussions on PMD Law Amendment; Will First Verify Results of Previous Amendment
April 12, 2018
- MHLW Panel to Kick Off Debates on Amendment of Pharmaceuticals and Medical Devices Law
April 5, 2018
REGULATORY
- War-Linked Supply Concerns Rise to 43 Cases, Focus Shifts to Solvents, Packaging
April 24, 2026
- JPMA Pushes for “Freeze” on On-Patent Drug Price Cuts at LDP Meeting
April 23, 2026
- MHLW to Exclude High School-Age and Younger from OTC-Like Drug Charge: Official
April 23, 2026
- Japan, Singapore to Share GMP Inspection Results under Cooperation Pact
April 23, 2026
- MHLW Orders Label Revisions for Remicade, Enbrel, Bavencio, and More Drugs
April 22, 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…





