- ICH Official web site : ICH
Founded 35 years ago and registered as a non-profit legal entity under Swiss law in 2015, ICH has finalised nearly 80 Guidelines that are applied by regulatory authorities around the world ICH has 25 members, 41 observers, and a network of close to 700 experts globally
- ICH Official web site : ICH
The ICH Harmonised Guideline was finalised under Step 4 in February 2002 This document is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability Guideline
- ICH Official web site : ICH
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)
- ICH Official web site : ICH
Explore ICH Efficacy Guidelines covering key principles and recommendations for the pharmaceutical sector to ensure effective and safe drug development
- ICH Official web site : ICH
The ICH Harmonised Guideline was finalised under Step 4 in November 2011 It replaces and combines the ICH S2A and S2B Guidelines The S2A Guideline on Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals was finalised under Step 4 in July 1995
- ICH Official web site : ICH
In order to facilitate the implementation of the CTD General (M4) Guideline, the ICH Experts have developed a series of Q As The document which reached Step 4 of the ICH Process in June 2004, intends to clarify the key issues regarding the CTD
- ICH Official web site : ICH
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as an international association, a legal entity under Swiss law
- ICH Official web site : ICH
About ICH Mission History Transparency Funding ICH Award Work with ICH Articles Procedures Work Plans Reports Organisational Chart Members Observers Value of Membership Application Process ICH Events ICH Events Assembly Meetings Management Committee Work Products Process of Harmonisation Public Consultations Guideline Implementation All
|