Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Announces 16 APIs as Candidates for Switch-OTC Status: None for Lifestyle Diseases
The Ministry of Health, Labor and Welfare (MHLW) announced on its website on December 9 a list of 16 active pharmaceutical ingredients (APIs) for which switch-OTC status has been requested by scientific societies, organizations, companies, and consumers (individuals) under the…
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
- Japan Resumes Debate on Rx-to-OTC Switch of PPIs after Over 5 Years
March 22, 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 Council Recommends Switching of 4 APIs; Switching of Levonorgestrel for Emergency Contraception Disapproved
July 28, 2017
- 6 APIs Added to List of “Switch OTC” Candidates: MHLW
June 26, 2017
- New Scheme on Switch OTC Gets Underway
April 14, 2016
REGULATORY
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 2026
- MHLW Official Says US MFN Policy Could Be Taken Up by Chuikyo
May 15, 2026
- Oncolys’ Telomelysin Up for Japan Panel Review on May 21
May 15, 2026
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 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…