Public Comment on Proposed Amendments to MHLW Designations of Class 1 and Class 2 OTC Drugs under the PMD Act
「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: 2026-09-09 · Source: e-Gov Public Comment · Stage: Public Comment Closed · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-10-09 00:00 JST · First detected by this dashboard: 2026-09-11
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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 (out for public comment) on draft amendments to the Minister of Health, Labour and Welfare's designations of certain Class 1 and Class 2 non-prescription drugs under Article 36-7 of Japan's Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (PMD Act), and to designations of certain Class 2 drugs requiring special caution under the Act's Enforcement Regulations. According to the metadata, the draft was published on 2026-09-09 with a comment deadline of 2026-10-09, and the responsible office is the Pharmaceutical Safety Division of the Pharmaceuticals Bureau. The classifications are proposed and not indicated as finalized.
Business Impact
Businesses involved in manufacturing, distributing, or selling affected non-prescription drugs may see changes in classification or handling requirements if the proposals are adopted.
Recommended Action
Consider reviewing the official Japanese source and the draft text via the provided e-Gov link to confirm the specific products and requirements affected.