Document:ICH ICH Guidelines -

Document information
Reference	ICH ICH Guidelines -
Validity area	ICH
Scope(s)	HM
Document name	ICH Guidelines
Version / Revision	-
Status	N.A.
Document type	Corpus of texts
Language(s)	EN
Description	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Q: Quality guidelines (conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management, …) - S: Safety Guidelines (uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity, non-clinical testing strategy for assessing the QT interval prolongation liability, …) - E: Efficacy Guidelines (design, conduct, safety and reporting of clinical trials) - M: Multidisciplinary Guidelines (cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology [MedDRA], the Common Technical Document [CTD] and the development of Electronic Standards for the Transfer of Regulatory Information [ESTRI])
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors