Act Amending the Pharmaceuticals and Medical Devices Act (Reiwa 7 Act No. 37); Clinical Trials Act listed
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
Published: 2025-05-21 · Source: e-Gov Law Search — Updated Laws · Stage: Scheduled to Take Effect · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-10-10
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
The e-Gov law update list shows an amending act, 'Act to Partially Amend the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc.' (Reiwa 7 Act No. 37), with a stated promulgation date of 2025-05-21. The entry concerns the Clinical Trials Act (Heisei 29 Act No. 16) as the target law and lists a scheduled enforcement date of 2027-05-20. The update list date given is 2026-10-09.
Business Impact
Organizations involved in clinical research, pharmaceuticals, or medical devices may be affected by revisions to the Clinical Trials Act, depending on the actual amended provisions. The specific changes and their scope are not described in the provided metadata.
Recommended Action
Review the official e-Gov text of the amending act and the amended Clinical Trials Act to confirm which provisions change and how the 2027-05-20 enforcement date applies.
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.
- 2025-05-21 — Promulgated (statute recorded by e-Gov Law Search) Original Japanese source
- 2027-05-20 — Effective date stated by e-Gov Law Search Original Japanese source