Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Resumes Debate on Rx-to-OTC Switch of PPIs after Over 5 Years
A Japanese health ministry panel has resumed discussions on the prescription-to-OTC switch of proton pump inhibitors (PPIs) more than five years after it rejected such proposal due to concerns over their long-term use. In December 2018, the Ministry of Health,…
To read the full story
Related Article
- Vonoprazan Gets Panel Backing for Rx-to-OTC Switch
August 25, 2025
- All Three PPI Switch OTCs Approved following MHLW Panel OK
July 14, 2025
- Pariet’s Nonprescription Versions Approved 6 Years after Discussions Start
March 25, 2025
- Health Ministry Panel Endorses RX-to-OTC Switches of 3 PPIs
December 23, 2024
- Japan Panel Backs Rx-to-OTC Switch of 4 PPIs
July 30, 2024
- Council Holds Off Nonprescription Switches of PPIs Despite Public Support
December 10, 2018
- MHLW Panel Rebuffs Nonprescription Switches of 3 PPIs
August 3, 2018
- Healthcare Experts at Odds over Nonprescription Switches of 3 PPIs
March 20, 2018
- MHLW Announces 16 APIs as Candidates for Switch-OTC Status: None for Lifestyle Diseases
December 13, 2016
REGULATORY
- War-Linked Supply Concerns Rise to 43 Cases, Focus Shifts to Solvents, Packaging
April 24, 2026
- JPMA Pushes for “Freeze” on On-Patent Drug Price Cuts at LDP Meeting
April 23, 2026
- MHLW to Exclude High School-Age and Younger from OTC-Like Drug Charge: Official
April 23, 2026
- Japan, Singapore to Share GMP Inspection Results under Cooperation Pact
April 23, 2026
- MHLW Orders Label Revisions for Remicade, Enbrel, Bavencio, and More Drugs
April 22, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…