Document:ICH ICH Guidelines -
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| 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 | |
