Public comment until 0:00 on Sep 24, 2026 | Draft revision of Class 1, Class 2 and Designated Class 2 lists
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.
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.
Japan begins pre-entry tuberculosis screening (JPETS) in Indonesia on Nov 2, 2026. From Jan 4, 2027, a TB-free certificate must be submitted with a Certificate of Eligibility or visa application.
Japan's Ministry of Health, Labour and Welfare is revising which diseases qualify as designated intractable diseases and the severity criteria for medical fee subsidies. Public comment runs to 29 October 2026 and applies to insured foreign residents too.
Japan's Ministry of Health, Labour and Welfare opened a public comment period on 7 September 2026 for a draft cabinet order arranging related orders for the partial enforcement of the Act amending the Social Welfare Act and others. Comments are accepted via e-Gov from 20:00 on 7 September until 20:00 on 7 October 2026, and anyone may submit regardless of nationality.
Source:
e-Gov Public Comment (Ministry of Health, Labour and Welfare website, Pharmaceutical Safety Division: draft revision of Class 1 and Class 2 medicine designations)This article was edited and written by freegent Inc. based on the source above.