REGULATORY
JMA Reps Oppose Reclassification of Epadel OTC despite No Serious ADR Reports: MHLW Safety Panel
Representatives from the Japan Medical Association (JMA) on a health ministry drug safety panel opposed on March 22 to reclassify a switch-OTC version of Mochida Pharmaceutical’s hyperlipidemia treatment Epadel (ethyl icosapentate), which is currently classified as a “behind-the-counter (BTC) drug”,…
To read the full story
Related Article
- Epadel OTC to Be Reclassified as “Class 1” Category under Stricter Rules on Sales: MHLW Panel
April 5, 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
- Japan Mulls Target on “Social Security Burden Rate” after CEFP Call
May 25, 2026
- Ishin Deepens Debate on Healthcare Macroeconomic Indexing
May 25, 2026
- Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
May 22, 2026
- Blister Pack Supplies Seen Returning to Normal: Health Minister
May 22, 2026
- LDP “Eto” Study Group Submits Honebuto Proposal to Health Minister
May 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…





