Public consultation on draft amendment to designated pharmaceuticals and periods
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: 2026-07-14 · Source: e-Gov Public Comment · Stage: Public Comment Closed · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · Comment deadline: 2026-08-14 00:00 JST · First detected by this dashboard: 2026-07-16
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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 public consultation announced on 2026/07/14 concerns a draft amendment to the pharmaceuticals and periods designated by the Minister of Health, Labour and Welfare under Article 216-2, paragraph 1 of the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The comment deadline is 2026/08/14 00:00, and the listed contact is the Pharmaceutical Safety Bureau, Compliance and Narcotics Division.
Business Impact
Businesses handling pharmaceuticals covered by the ministerial designation may be affected by changes to the designated pharmaceuticals or periods; the listing does not identify the products or proposed changes.
Recommended Action
Review of the official consultation materials could clarify which pharmaceuticals and periods would change and confirm the comment submission requirements and deadline.