Amendment to Ordinance on Designated Substances and Medical Uses under 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二条第十五項に規定する指定薬物及び同法第七十六条の四に規定する医療等の用途を定める省令の一部を改正する省令
Published: 2026-08-27 · Source: e-Gov Law Search — Updated Laws · Stage: In Force · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-09-10
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 item is a Ministry of Health, Labour and Welfare ordinance amending an existing ordinance that specifies designated substances under Article 2, Paragraph 15 and medical or other uses under Article 76-4 of Japan's Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Other Products (PMD Act). According to the metadata, the amending ordinance is MHLW Ordinance No. 135 of 2026, with a stated promulgation date of 2026-08-27 and a stated effective date of 2026-09-06. The original ordinance is identified as MHLW Ordinance No. 14 of 2007.
Business Impact
Businesses handling pharmaceuticals or substances regulated under the PMD Act may be affected if the amendment changes which substances are designated or which medical uses are recognized. The specific scope of changes is not detailed in the provided metadata.
Recommended Action
Consider reviewing the official Japanese ordinance text via the e-Gov Law Search source to confirm the exact scope, designated substances, and effective date.
Timeline of related official records
Related official records are linked only when names and instrument numbers match exactly, so this timeline may be incomplete. Dates are as stated by the official sources. It is a monitoring aid, not legal advice; the original Japanese sources are authoritative.
- 2026-08-27 — Promulgated (instrument recorded by e-Gov Law Search) Original Japanese source
- 2026-09-06 — Effective date stated by e-Gov Law Search Original Japanese source