Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
OxyContin Gets Delayed Approval in Japan with Special Distribution Scheme Now in Place
The Ministry of Health, Labor and Welfare (MHLW) on October 29 approved Shionogi’s opioid analgesic OxyContin (oxycodone) for an additional indication of chronic pain with a seven-month delay from the typical timeline as it sees a special distribution scheme now…
To read the full story
Related Article
REGULATORY
- Revolade, Bilanoa See First Generics in June Listing; 3 Final AGs on Roster
June 11, 2026
- Official Hints at Potential Change to Growth Target in Draft Roadmap
June 11, 2026
- Ishin Proposes Adding Drug, Device Makers to Chuikyo, LDP Wary
June 10, 2026
- Cabinet Approves Immunization Act Revision to Cover Antibody Drugs
June 10, 2026
- LDP Lawmakers Seek Routine HPV Vaccinations for Males by April 2027
June 10, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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…