欧州における医薬品環境リスクアセスメントに関する最新の規制ガイドライン

浦野 浩行; Höger Stefan; 林 俊英; 小野寺 博志; 中江 大; 安齋 享征; 松山 高明

doi:10.11403/jset.29.22

Brief Communication

New regulatory guideline on environmental risk assessment for pharmaceutical products in EU

Hiroyuki Urano , Stefan Höger, Toshihide Hayashi, Hiroshi Onodera, Dai Nakae, Takayuki Anzai, Takaaki Matsuyama

Author information

Keywords: pharmaceuticals, environmental risk assessment, guidelines, EMA

JOURNAL OPEN ACCESS

2026 Volume 29 Issue 1 Pages 22-35

DOI https://doi.org/10.11403/jset.29.22

Details

Abstract

In the European Union, a revised version of the “Guideline on Environmental Risk Assessment of Medicinal Products for Human Use” (EMEA/CHMP/SWP/4447/00) came into effect in September, 2024. This review explains the revised contents of the Guideline, summarizes points to note when conducting an environmental risk assessment, and proposes a useful project model for the pharmaceutical industry.

Corresponding author

Register with J-STAGE for free!