💊 OTC Drug Risk Classes Under Review

❓ What is changing?

On August 25, 2026 the Ministry of Health, Labour and Welfare published two draft notifications revising how over-the-counter (OTC) medicines are classified, and opened them for public comment. The first amends the list of "Class 1" and "Class 2" medicines designated by the Minister under Article 36-7, Paragraph 1, Items 1 and 2 of the Pharmaceuticals and Medical Devices Act. The second amends the list of Class 2 medicines designated as "requiring special caution" (Designated Class 2) under Article 1-2, Paragraph 3, Item 5 of the Act's enforcement regulations. OTC medicines are sorted by the side-effect risk of their ingredients, and the class decides how a drug is handled in the store. Class 1 may be sold only by a pharmacist, who must provide written information at purchase. Class 2 and Designated Class 2 may be sold by a pharmacist or a registered seller, with Designated Class 2 carrying extra warnings for children, pregnant women and people with existing conditions. This revision does not change the system itself — it moves individual products between the designation lists. Once finalized, the same familiar medicine may be bought in a different way and come with a different explanation. Comments are accepted from 9:00 on August 25 until 0:00 on September 24, 2026.

👥 Who is affected?

• ●Foreign residents who buy OTC medicines at drugstores or pharmacies
• ●Households that keep OTC cold, painkiller or stomach medicines on hand
• ●Visitors to Japan who buy OTC medicines while traveling
• ●People who order medicines through online pharmacies
• ●Anyone who wants to submit an opinion (until 0:00 on Sep 24, 2026)

🌏 Impact on foreign residents and visitors

In Japan, the class printed on the box decides whether you can pick a medicine off the shelf yourself or must ask a pharmacist at the counter. If a product moves from Class 2 up to Class 1, you can no longer buy it when no pharmacist is on duty or at stores without one, and you must go through a written explanation at purchase. If it moves down, stores with a registered seller can hand it over more easily. Because that counseling is normally done in Japanese, a language barrier can turn into a "my usual medicine is not available today" moment. For travelers, it directly affects whether a specific medicine is available late at night or near an airport. Designated Class 2 carries extra warnings for pregnant or breastfeeding people, children and those with chronic conditions, so check the label when buying for family members.