Japan's health ministry wants to move a common over-the-counter pain reliever into a less restrictive OTC category. The Ministry of Health, Labour and Welfare opened a public comment period on August 25, 2026, running to September 23, 2026, on a proposal to reclassify oral loxoprofen, excluding external preparations and products intended to relieve cold symptoms, from a Class 1 OTC drug to a "Designated Class 2" OTC drug.
The shift matters for drugstore economics. Under the proposed Designated Class 2 status, a registered sales clerk could complete the sale alongside a pharmacist, provided staff use a checklist to walk first-time buyers through dosage limits and warnings.
| Feature | Current Status | Proposed Status |
|---|---|---|
| Risk classification | Class 1 OTC drug | Designated Class 2 OTC drug |
| Who can complete the sale | Not specified in this filing | Registered sales clerk or pharmacist, with checklist-based explanation for first-time buyers |
| Product scope | Oral-route loxoprofen | Same scope; external preparations and products intended to relieve cold symptoms remain excluded |
| Effective date | N/A | Undetermined; to be gazetted alongside the safety designation change |
The reclassification follows a July 29, 2026 review by the Pharmaceutical Affairs Council's safety measures subcommittee, which found loxoprofen's side-effect record supported the change only if manufacturers and retailers tighten how the drug is sold. Makers must redesign boxes and package inserts to make single-dose limits and warnings against continuous long-term use more prominent, flag more clearly that a product contains loxoprofen, and highlight that the drug cannot be taken by women within 12 weeks of their due date. They must also supply retailers with purchase checklists and comparison materials for same-brand products with different ingredients, plus training packets for registered sales clerks handling loxoprofen for the first time. The manufacturers that submitted supporting data for this review must additionally survey post-transition sales and adverse-event data and report the results to the ministry's safety panel.
Retailers carry matching obligations. Registered sales clerks must complete training before their first loxoprofen sale and periodically afterward, covering pain relievers broadly rather than loxoprofen alone, and first-time buyers must get a checklist-based explanation from staff before they can purchase it.
The committee separately flagged that brand names covering multiple formulations confuse buyers and questioned whether Japan's current "best-effort" information standard for Class 2 drugs remains adequate, a debate the ministry says will continue apart from this filing. No gazette date or effective date has been set; the plan is to enact the drug reclassification and the safety-designation change at the same time once finalized. Comments can be filed through the e-Gov portal, by mail, or by email to the ministry's pharmaceutical safety division before the September 23 deadline.