Public Comment: Draft Designation of Pharmaceuticals by the MHLW Minister under Article 68-2(1) of 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六十八条の二第一項の規定に基づき厚生労働大臣の指定する医薬品（案）」に関する御意見の募集について
Published: 2026-09-11 · Source: e-Gov Public Comment · Stage: Public Comment Closed · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-10-10 00:00 JST · First detected by this dashboard: 2026-09-13
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 invitation on a draft designating pharmaceuticals to be specified by the Minister of Health, Labour and Welfare under Article 68-2, paragraph 1 of Japan's Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act). According to the metadata, the draft was posted on 2026-09-11 with a comment submission deadline of 2026-10-10. The inquiry contact is listed as the Pharmaceutical Safety Division of the Pharmaceutical Affairs Bureau.
Business Impact
Organizations dealing with the affected pharmaceuticals may want to monitor this proposal, as a finalized designation could affect related safety or information-provision obligations.
Recommended Action
Review the official e-Gov public comment notice and the Japanese source to confirm the scope of the proposed designation and the submission deadline.