Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
New “Compassionate Use” System to Be Introduced in FY2015; Will Apply to Industry-Sponsored Trials as well as IITs
The Ministry of Health, Labor and Welfare (MHLW) presented an overview of a new compassionate use system at a meeting of the Pharmaceutical Affairs and Food Sanitation Council’s Pharmaceutical Affairs Council on December 18. The system will expand access to…
To read the full story
Related Article
- “Humanitarian Trials” Hefty Burden on Drug Makers: JPMA Regulatory Head
July 10, 2015
- Japan-Version Compassionate Use May Cover Drugs with No Approval Globally
January 26, 2015
- Pilot Program for Compassionate Access System Gets Underway with Sanofi’s Cabazitaxel
May 7, 2014
- Gov’t to Fully Implement Japan Version of “Compassionate Use” System in FY2015
January 23, 2014
- Pilot Program for Japan-Version “Compassionate Use” System to Begin at National Cancer Center
July 23, 2013
REGULATORY
- Officer Replacement Orders a “Last Resort” under PMD Act: MHLW Official
September 18, 2026
- Japan Panel Sees No Scientific Objection to Capvaxive NIP Addition
September 18, 2026
- Tavneos Blue Letter Action “Too Slow,” MHLW Panel Member Says
September 18, 2026
- Takaichi Tasks Ueno with Charting Growth Strategy for Drug Innovation
September 18, 2026
- Japan HIV, AIDS Cases Rise in H1 after 2025 Lows
September 18, 2026
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…