Many members of a key Japanese health ministry panel on January 12 called for the improved application of a newly established emergency approval system, which was first applied in November to Shionogi’s COVID-19 treatment Xocova Tablets (ensitrelvir). The calls were…
To read the full story
Related Article
- LDP Lawmakers Want Specific Definitions for Emergency Approval Prerequisites
January 18, 2022
- Significance and Challenges around Proposed Emergency Approval Scheme, Eyes on Diet Debate
January 17, 2022
- Govt to Submit PMD Law Amendment Bill in Ordinary Diet Session to Introduce Emergency Approval
January 7, 2022
- MHLW Finalizes Paper on Emergency Approval System, Set to Submit Bill Next Year
December 28, 2021
- Japan to Revise PMD Law to Create Emergency Approval System, Final Paper Due Out by Year-End
December 23, 2021
- Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
December 6, 2021
- MHLW Eyes Emergency Approval System Based on “Presumed” Efficacy
December 2, 2021
- Japan Panel Discusses Safety, Immunity Rules for Envisaged Emergency Approval Scheme
November 19, 2021
REGULATORY
- LDP Pharma Project Team to Compile Roadmap Proposals after Industry Hearings
April 17, 2026
- DPJ Leader to Urge Drug Price Hikes, “Freeze” on Off-Year Revisions
April 17, 2026
- War-Linked Supply Impact Cases Climb to 34 as Japan Steps Up Response
April 17, 2026
- Meiji Pharma Chair Prods Drug Price Hikes as War Drives Up Costs: Diet
April 17, 2026
- Japan Eases Documentation Requirements for Excipients Listed in Foreign Pharmacopoeias
April 17, 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…





