Act Amending the Pharmaceuticals and Medical Devices Act (PMD Act) and Related Laws (Act No. 37 of 2025)
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 records an amending act (Reiwa 7 Act No. 37) that amends the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. (Showa 35 Act No. 145) and related laws. The metadata lists a promulgation date of 2025-05-21 and an enforcement date of 2027-05-20. The provided metadata does not describe the specific amendments.
Business Impact
Companies in the pharmaceutical and medical device sectors may be affected once the amendments take effect, but the nature and scope of any changes cannot be determined from the provided metadata.
Recommended Action
Review the official Japanese text of the amending act and its enforcement provisions on e-Gov to confirm the actual amendments and whether they are relevant to your operations.
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