Cabinet Order amending related orders for pharmaceutical and medical device law changes

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

Cabinet Order No. 1 of 2021 amends related Cabinet Orders in connection with partial implementation of an Act amending the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other laws. The identified amended instrument is the Enforcement Order of the Act on the Pharmaceuticals and Medical Devices Agency, Cabinet Order No. 83 of 2004. The stated promulgation date is 2021-01-05 and the effective date is 2021-08-01.

Business Impact

The Pharmaceuticals and Medical Devices Agency may be affected because the identified amendment concerns the Enforcement Order of its governing Act; the metadata does not establish specific operational effects or obligations for pharmaceutical or medical device businesses.

Recommended Action

Reviewing the official Japanese source may clarify which provisions of the Agency's Enforcement Order were amended and whether any transitional provisions apply.

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. 2021-01-05 — 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関係政令の整備等に関する政令（令和三年政令第一号） (this update) Original Japanese source
2. 2021-08-01 — Effective date stated by e-Gov Law Search 独立行政法人医薬品医療機器総合機構法施行令 (this update) Original Japanese source