Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Pfizer’s BA.4/5-Adapted Comirnaty Grabs Special Approval in Japan
The Ministry of Health, Labor and Welfare (MHLW) on October 5 granted a special approval to Pfizer’s bivalent COVID-19 vaccine Comirnaty RTU tailored to the BA.4/BA.5 Omicron subvariants. The green light was given as a partial modification to the previous…
To read the full story
Related Article
- Japan to Roll Out BA.4/5 Omicron Boosters on Oct. 13, Inoculations for 6 Months to 4 Years from Oct. 24
October 11, 2022
- MHLW Panel to Discuss Shortening of COVID Booster Interval
October 11, 2022
- Comirnaty Bags Special Approval in Japan for Kids Aged 6 Months to 4 Years
October 6, 2022
- Moderna Files BA.4/5-Tailored COVID-19 Vaccine in Japan
October 5, 2022
- Japan Panel to Discuss Comirnaty for Kids Aged 6 Months to 4 Years on Oct. 5
September 29, 2022
- Pfizer Seeks Japan Nod for BA.4/5-Adapted COVID-19 Vaccine
September 13, 2022
- Japan OKs Omicron COVID-19 Vaccines from Pfizer, Moderna
September 13, 2022
- Moderna to File BA.4/5-Targeting Booster Jab in Japan
September 6, 2022
- Pfizer Discussing Filing of BA.5-Based Vaccine with Japanese Authorities
September 1, 2022
- Pfizer Seeks Japan Nod for Omicron-Adapted Bivalent Jab
August 9, 2022
REGULATORY
- MHLW Moves Toward Immunization Act Revision for RSV Antibody Drugs
May 21, 2026
- Japan Approves Nonprescription Cialis, Rozerem
May 21, 2026
- MHLW Panel Clarifies Roles in Vaccine Policy Review Process
May 21, 2026
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
- LDP Study Group’s Honebuto Proposal Urges “Freeze” on On-Patent Drug Price Cuts
May 20, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…