MHLW Ordinance Amending Regulations to Implement Revisions to the Pharmaceuticals and Medical Devices Act
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: 2026-06-30 · Source: e-Gov Law Search — Updated Laws · Stage: Scheduled to Take Effect · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-08-19
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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
This is a Ministry of Health, Labour and Welfare (MHLW) ordinance associated with the partial enforcement of a law amending the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Others. According to the metadata, it amends the Enforcement Regulations of the Medical Care Act (originally Ministry of Health and Welfare Ordinance No. 50 of 1948), with the amending ordinance recorded as MHLW Ordinance No. 110 of 2026. The metadata lists a promulgation date of 2026-06-30 and a scheduled effective date of 2027-05-20.
Business Impact
Organizations in the healthcare and pharmaceuticals sector may need to review how these amended MHLW regulations could affect their compliance obligations. The changes could have implications for entities subject to the Medical Care Act enforcement regulations.
Recommended Action
Consider reviewing the official Japanese source on e-Gov Law Search to confirm the scope, content, and timing of the amendments.
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.
- 2026-06-30 — 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