Guidance Document - Ethnic Factors in the Acceptability of Foreign Clinical Data ICH Topic E5(R1)

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

Data and Resources

Additional Info

Field Value
Last Updated April 17, 2026, 21:34 (UTC)
Created April 17, 2026, 21:34 (UTC)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2017-05-18 00:00:00
open_canada_keywords {"fr": ["document d'orientation", "facteurs ethniques", "acceptabilité des données cliniques étrangères", "ICH thème E5(R1)"], "en": ["guidance document", "ethnic factors", "acceptability-of foreign clinical data", "ICH Topic E5(R1)"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Ligne directrice - Facteurs ethniques influant sur l'acceptabilité des données cliniques d'origine étrangère ICH thème E5(R1)
update_frequency as_needed