Ministerial Ordinance amending post-marketing safety management standards for pharmaceuticals and devices
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等の一部を改正する法律の一部の施行に伴う厚生労働省関係省令の整備等に関する省令
Published: 2026-09-30 · Source: e-Gov Law Search — Updated Laws · Stage: Scheduled to Take Effect · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-10-20
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
Ministry of Health, Labour and Welfare Ordinance No. 142 of 2026 was promulgated on 2026-09-30, with a stated effective date of 2027-05-20, to adjust ministry ordinances in connection with partial implementation of an Act amending the law on the quality, efficacy and safety of pharmaceuticals and medical devices and other laws. It amends the Ordinance on Standards for Post-Marketing Safety Management of Pharmaceuticals, Quasi-Drugs, Cosmetics, Medical Devices and Regenerative Medical Products (Ministry of Health, Labour and Welfare Ordinance No. 135 of 2004).
Business Impact
Marketing authorization holders for pharmaceuticals, quasi-drugs, cosmetics, medical devices and regenerative medical products may be affected by changes to post-marketing safety management standards; the listing does not specify the substantive changes.
Recommended Action
Review of the official Japanese amendment and revised ordinance would help identify the changed safety management provisions and any transitional arrangements associated with the stated 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.
- 2026-09-30 — Promulgated (instrument recorded by e-Gov Law Search) Original Japanese source
- 2027-05-20 — Effective date stated by e-Gov Law Search Original Japanese source