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.

Données et ressources

Info additionnelle

Champ Valeur
Source
Version
Producteur
Courriel de l'auteur
Mainteneur
Courriel du mainteneur
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French) Ligne directrice - Facteurs ethniques influant sur l'acceptabilité des données cliniques d'origine étrangère ICH thème E5(R1)
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
Langue
Contact Person
Contact Email
Dictionnaire de données
Open Canada Date Published 2017-05-18 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
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 Collection publication
Principal Organization
Reference Data
Official Source