MHLW ordinance amending manufacturing and quality control standards for drugs and quasi-drugs
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: 2026-10-20
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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 a stated effective date of 2027-05-20. It amends the Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (Ministry of Health, Labour and Welfare Ordinance No. 179 of 2004) as part of adjustments to ministry ordinances accompanying partial implementation of an Act amending legislation on the quality, efficacy and safety of pharmaceuticals and medical devices.
Business Impact
Manufacturers of drugs and quasi-drugs may be affected through changes to manufacturing and quality control standards; the supplied information does not identify the specific requirements changed.
Recommended Action
Review the official Japanese ordinance to identify the amended manufacturing and quality control provisions and any transitional arrangements associated with the 2027-05-20 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