Draft designation of pharmaceuticals under Article 36-3(2) of the Pharmaceuticals and Medical Devices 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三第二項の規定に基づき厚生労働大臣が指定する医薬品（案）に関する御意見の募集について
Published: 2026-10-16 · Source: e-Gov Public Comment · Stage: Public Comment Open · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-11-14 23:59 JST · First detected by this dashboard: 2026-10-18
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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
A draft concerning pharmaceuticals designated by the Minister of Health, Labour and Welfare under Article 36-3(2) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was published for public comment on 2026-10-16. The stated comment deadline is 2026-11-14 23:59 JST, and the listed contact is the General Affairs Division, Pharmaceutical Safety Bureau.
Business Impact
Businesses handling pharmaceuticals covered by the proposed designation may be affected; the available information does not identify the pharmaceuticals or explain the designation's practical effects.
Recommended Action
Reviewing the official Japanese draft would help identify the pharmaceuticals proposed for designation and the implications of Article 36-3(2).