PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
Japan Rolls Out Full-Fledged Sakigake System, Designations 2 Times a Year with Tougher Revocation Rules
The Ministry of Health, Labor and Welfare (MHLW) on September 1 fully introduced the sakigake designation system, under which it will now invite applications all year long and designate products twice a year, around April and October for the time…
To read the full story
Related Article
- 2 Years after Full Rollout, Sakigake System Shows Tepid Uptake as Industry Sees Poor Incentives
September 21, 2022
- MHLW to Draft Guidelines by Year-End on Use of Patient Registry Data in Drug Filing
October 5, 2020
- Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
September 8, 2020
- MHLW to Accept Sakigake Applications All Year Long under Amended PMD Law
August 27, 2020
REGULATORY
- AbbVie’s Fast-Acting Botulinum Toxin Boey Wins Japan Panel Backing
October 27, 2026
- LDP Lawmakers Renew Push for Routine HPV Shots for Males by April 2027
October 27, 2026
- LDP Study Group Eyes Policy Proposals to Shore Up Drug Supplies
October 27, 2026
- FPMAJ Seeks Higher Drug Prices to Bolster Supply Security: LDP Confab
October 27, 2026
- PMDA Says IT Systems Could Go Offline Without Warning
October 27, 2026





