Ministerial Ordinance Amending Pharmaceutical and Medical Device Act Enforcement Regulations
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の一部を改正する省令
Published: 2026-08-24 · Source: e-Gov Law Search — Updated Laws · Stage: In Force · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-09-09
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. 133 of 2026 amends the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Ministry of Health and Welfare Ordinance No. 1 of 1961). The listed promulgation and effective dates are both 2026-08-24; the amended provisions are not described.
Business Impact
Businesses handling pharmaceuticals and medical devices may be affected by changes to the enforcement regulations, but the specific activities and requirements affected cannot be determined from the listing.
Recommended Action
Review of the official Japanese ordinance would help identify the amended provisions, their scope and any transitional arrangements.
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.
- 2026-08-24 — Promulgated (instrument recorded by e-Gov Law Search) Original Japanese source
- 2026-08-24 — Effective date stated by e-Gov Law Search Original Japanese source