Ministerial Ordinance amending pharmaceutical post-marketing study and trial standards

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 Ministerial Ordinance on Standards for Conducting Post-Marketing Studies and Trials of Pharmaceuticals (Ministry of Health, Labour and Welfare Ordinance No. 171 of 2004), as part of adjustments accompanying partial implementation of an Act amending the law on the quality, efficacy and safety of pharmaceuticals and medical devices and other laws.

Business Impact

Those conducting pharmaceutical post-marketing studies and trials may be affected by changes to the standards governing those activities; the listing does not specify the amended requirements.

Recommended Action

Review of the official Japanese source could clarify the amended standards, their scope and any transitional provisions 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.

1. 2026-09-30 — Promulgated (instrument recorded by e-Gov Law Search) 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（令和八年厚生労働省令第百四十二号） (this update) Original Japanese source
2. 2027-05-20 — Effective date stated by e-Gov Law Search 保険薬局及び保険薬剤師療養担当規則、再生医療等の安全性の確保等に関する法律施行規則、医療機器の製造販売後の調査及び試験の実施の基準に関する省令、医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令、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施行規則 ほか9件 (this update) Original Japanese source