The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
REGULATORY
First Drug Maker Applies to Use MID-NET: PMDA
The Pharmaceuticals and Medical Devices Agency (PMDA) received the first application to use its MID-NET medical information database, which was launched by the agency in April, from a drug maker. The PMDA will review the application via its internal panel…
To read the full story
Related Article
- MSD to Tap MID-NET Database for Erelsa/Grazyna in 3rd Private Sector Use
January 29, 2019
- Pfizer to Use MID-NET Database for Ibrance PMS
September 19, 2018
- Second Applicant from Pharma Companies to Use MID-NET: PMDA
September 19, 2018
- PMDA Reveals First 2 Cases of MID-NET Regulatory Use
July 2, 2018
- PMDA Reveals Zero Company Request So Far for MID-NET Database Use, but Says Several Interested
June 19, 2018
REGULATORY
- PMDA Halts Medical Device Application Platform after Unauthorized Access
October 30, 2026
- Chuikyo Reps Back More Pharma Access to CEA Deliberations, Urge Neutrality
October 29, 2026
- FY2027 Revision: HCPs Press for Action on Drug Shortages, Negative Margins
October 29, 2026
- Zolgensma Cost-Effectiveness Analysis to Resume after Five-Year Halt
October 29, 2026
- Japan Eyes Priority Review for MCMs, Bill Submission Planned for 2027
October 28, 2026
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…
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…