Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance

Q8, Q9 and Q10 Questions & Answers (R4). 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.

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Champ	Valeur
Dernière modification	avril 17, 2026, 17:54 (TU)
Créé le	avril 17, 2026, 17:54 (TU)
criticality_level	[]
geographic_scope	[]
open_canada_collection	publication
open_canada_date_published	2020-12-09 00:00:00
open_canada_keywords	{"fr": ["conférence internationale sur l'harmonisation", "ICH", "ICH des exigences techniques", "enregistrement des produits pharmaceutiques", "produits pharmaceutiques à usage humain", "lignes directrices de l'ICH Q8", "Q9 et Q10 Foire aux questions (R4)."], "en": ["international-conference on harmonisation", "ICH", "ICH of technical-requirements", "registration of pharmaceuticals", "pharmaceuticals for human-use", "ICH guidance", "Q8", "Q9", "Q10", "Questions & Answers (R4)"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	L'adoption pour l'International Conference on Harmonisation of Technical Requirements for the Registration Of Pharmaceuticals For Human Use (lICH) ligne directrice
update_frequency	as_needed