Public Comment: Draft Amendments to MHLW Designations of Class 1 and Class 2 Non-Prescription Drugs
「医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律第三十六条の七第一項第一号及び第二号の規定に基づき厚生労働大臣が指定する第一類医薬品及び第二類医薬品の一部を改正する件（案）」及び「医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律施行規則第一条の二第三項第五号の規定に基づき特別の注意を要するものとして厚生労働大臣が指定する第二類医薬品の一部を改正する件（案）」に関する御意見の募集について
Published: 2026-08-25 · Source: e-Gov Public Comment · Stage: Public Comment Closed · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-09-24 00:00 JST · First detected by this dashboard: 2026-08-26
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AI summary
Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.
Summary
This is a public comment consultation on two draft amendments concerning the designation of certain non-prescription (OTC) drugs under Japan's Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. One draft revises the Minister of Health, Labour and Welfare's designations of certain Class 1 and Class 2 drugs, and the other revises the designation of certain Class 2 drugs requiring special caution. The draft was published on 2026-08-25 with comments accepted until 2026-09-24.
Business Impact
Businesses that manufacture, distribute, or sell affected non-prescription drugs may need to monitor how these classification designations could change handling or sales requirements. The proposals are still at the draft stage and could be modified before any finalization.
Recommended Action
Consider reviewing the official e-Gov public comment notice and the linked draft texts to confirm scope, affected products, and the comment deadline.