Public comment: draft amendment to MHLW list of designated OTC-guidance (yo-shido) 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四条第五項第三号の規定に基づき厚生労働大臣が指定する要指導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: 2026-10-01 · Source: e-Gov Public Comment · Stage: Public Comment Open · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-10-31 00:00 JST · First detected by this dashboard: 2026-10-01
View the original Japanese source More Healthcare / Pharmaceuticals updates Search all updates in the dashboard
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 solicitation on a draft (proposed) notice that would partly amend the list of 'drugs requiring guidance' (yo-shido iyakuhin) designated by the Minister of Health, Labour and Welfare under Article 4, paragraph 5, item 3 of the Pharmaceuticals and Medical Devices Act. The draft was announced on 2026/10/01 and comments are accepted until 2026/10/31 00:00. The inquiry contact is the Pharmaceutical Evaluation Division of the Ministry of Health, Labour and Welfare (MHLW).
Business Impact
If adopted, the amendment could change which drugs are designated as requiring guidance, which may affect how affected products are classified, sold, or labeled. The specific products and practical effects are not stated in the provided metadata.
Recommended Action
Review the official Japanese public comment page and the attached draft to confirm which designations would change and whether the comment deadline is relevant to your products.