Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Review Report: Pfizer Vaccine’s Efficacy for Variants Not Gauged in Clinical Trials, Continued Info Collection Needed
The Pharmaceuticals and Medical Devices Agency (PMDA) released its review report for Pfizer/BioNTech’s COVID-19 vaccine on February 15, just a day after the product was granted fast-track approval under the name of Comirnaty. In its review report, the PMDA concluded…
To read the full story
Related Article
- 2nd-Dose Shot Starts for COVID-19 Vaccination in Japan
March 12, 2021
- PAFSC Minutes for Pfizer Vaccine Disclosed
March 1, 2021
- Japan Launches COVID-19 Vaccination Program
February 18, 2021
- COVID-19 Vaccine Being Rolled Out for 40,000 Healthcare Workers in Japan
February 17, 2021
- Pregnant Women Not Urged to “Make Efforts” to Get COVID-19 Vaccines
February 16, 2021
- Japan Approves Pfizer’s COVID-19 Vaccine, Rollout Set for Mid Week
February 15, 2021
- Pfizer’s COVID-19 Shot Up for PAFSC Review Feb. 12, Kono Expects Govt to Secure Enough Doses for 1st-in-Line HCPs
February 9, 2021
- Japan Moves Up Vaccine Rollout Target to Mid-February, PAFSC Review on Feb. 12?
February 3, 2021
- Japan to Set Up Real-Time Tracking System for COVID-19 Vaccination: Kono
January 26, 2021
- Japan Preps for COVID-19 Vaccine Rollout for HCPs by Late February: Minister
January 25, 2021
- Japan Govt Starts COVID-19 Vaccine Website, Plans Air/Land Shipments by Logistics Firms for Pfizer Shots
January 25, 2021
- Japan, Pfizer Finalize COVID-19 Vaccine Deal, Agree on Supply of 144 Million Doses
January 21, 2021
- Govt Eager to Roll Out 1st COVID-19 Vaccine by Late February; PM Says Pfizer’s Japan Data Ready by Month-End
January 5, 2021
- Decision on Pfizer Vaccine Unlikely to Come before Japan Data Submission Slated by February
December 21, 2020
- Pfizer/BioNTech’s COVID-19 Vaccine Filed in Japan, Exceptional OK Eyed
December 18, 2020
REGULATORY
- Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
May 22, 2026
- Blister Pack Supplies Seen Returning to Normal: Health Minister
May 22, 2026
- LDP “Eto” Study Group Submits Honebuto Proposal to Health Minister
May 22, 2026
- Oncolys’ Telomelysin Wins Backing from Japan Panel
May 22, 2026
- MHLW Moves Toward Immunization Act Revision for RSV Antibody Drugs
May 21, 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…