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 …

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 …

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).

The ICH Harmonised Guideline was finalised under Step 4 in November 2003. This document provides a standardised procedure for post-approval safety data management and the guidance for gathering …

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to …

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 …

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, …

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 …

The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory …

The ICH Assembly meets on a biannual basis in conjunction with meetings of the ICH Management Committee, ICH MedDRA Management Committee and ICH technical Working Groups.