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 ICH S5 (R3) provides human safety assurance at least equivalent to that provided by current testing paradigms. In addition, this revision intends to provide greater clarity and alignment with other ICH …

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions …

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss the …

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to …

About ICH Mission History Transparency Funding ICH Award Work with ICH Articles & Procedures Work Plans & Reports Organisational Chart Members & Observers Value of Membership Application …

Jan 15, 2026 · Both of these Guidelines are related to ICH’s harmonised electronic standards work, which is advanced by ICH Expert Working Groups and also through joint initiatives with other …