MHLW Ministerial Ordinance amending the Clinical Research 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: 2026-10-17
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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
Ministry of Health, Labour and Welfare Ordinance No. 142 of 2026 was promulgated on 2026-09-30, with an effective date of 2027-05-20. It amends the Clinical Research Act Enforcement Regulations (Ministry of Health, Labour and Welfare Ordinance No. 17 of 2018) as part of adjustments to ministry ordinances accompanying partial implementation of an Act amending the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other laws.
Business Impact
Those conducting clinical research may be affected by changes to the Clinical Research Act Enforcement Regulations; the listed amendment concerns clinical research specifically, rather than pharmaceutical and medical-device activities generally. The metadata does not identify the provisions changed or their operational effects.
Recommended Action
Reviewing the official Japanese ordinance and amended Clinical Research Act Enforcement Regulations would help clarify the affected provisions, any transitional arrangements, and 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