Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Epadel OTC to Be Reclassified as “Class 1” Category under Stricter Rules on Sales: MHLW Panel
A health ministry’s drug safety panel approved on April 2 the reclassification of a switch-OTC version of Mochida Pharmaceutical’s hyperlipidemia treatment Epadel (ethyl icosapentate), which is currently classified as a “behind-the-counter (BTC) drug”, as a Class 1 OTC drug under…
To read the full story
Related Article
- No More Nonprescription Switches for Lifestyle Disease Drugs, Says JMA Exec
April 5, 2019
- JMA Reps Oppose Reclassification of Epadel OTC despite No Serious ADR Reports: MHLW Safety Panel
March 26, 2019
- At Request of JMA, Pharmacists to Be Required to Confirm that Buyers of Switch OTC Version of Epadel Had Medical Exam Before Purchase
January 15, 2013
- PAC Approves OTC Switching of Epadel
December 21, 2012
- MHLW to Initially Limit Number of Stores to Offer Epadel OTC
October 26, 2012
- PAFSC Committee Recommends Approval for Switch OTC Version of Epadel 2 Years after Frist Review
October 18, 2012
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…