Public Comment on Draft Amendment to List of Designated Guidance-Required Drugs (MHLW)
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: 2026-08-20 · Source: e-Gov Public Comment · Stage: Public Comment Closed · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-09-20 00:00 JST · First detected by this dashboard: 2026-08-20
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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 invitation from Japan's Ministry of Health, Labour and Welfare regarding a draft amendment to the list of guidance-required drugs (yo-shido iyakuhin) designated by the Minister under Article 4, Paragraph 5, Item 3 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, and Other Products. According to the metadata, the draft was published on 2026-08-20 with a comment submission deadline of 2026-09-20. The item is categorized under health/welfare, with inquiries handled by the MHLW Pharmaceutical Evaluation Division.
Business Impact
Changes to which drugs are designated as guidance-required could affect how certain pharmaceutical products are sold or dispensed, which may be relevant to businesses in the pharmaceutical and retail pharmacy sectors.
Recommended Action
Consider reviewing the official e-Gov public comment notice and the underlying draft to confirm the specific drugs and provisions affected before the stated submission deadline.