Public Comment: Draft Amendment to Designated Drugs and Periods under PMD Act Enforcement Regulation Art. 216-2(1)
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二百十六条の二第一項の規定に基づき厚生労働大臣が指定する医薬品及び期間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: 2026-06-15 · Source: e-Gov Public Comment · Stage: Public Comment Closed · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-07-16 00:00 JST
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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 item from e-Gov regarding a draft amendment to the list of pharmaceuticals and periods designated by the Minister of Health, Labour and Welfare under Article 216-2, paragraph 1 of the Enforcement Regulation of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices. The draft was published on 2026-06-15, with a comment submission deadline of 2026-07-16. The matter is handled by the Compliance and Narcotics Division of the Pharmaceutical Safety Bureau.
Business Impact
Entities handling the affected pharmaceuticals may need to monitor potential changes to designated drugs and applicable periods, which could affect related compliance obligations.
Recommended Action
Consider reviewing the official Japanese source on e-Gov to confirm the scope of the proposed designations and the comment submission deadline.