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. …

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 …

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 …

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 …

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 …

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 …

In May 2005, an M5 consensus draft Guideline containing ICH business requirements for medicinal product identifiers, along with lists of controlled vocabularies for Routes of …

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 …

Jan 14, 2025 · The ICH E6 (R3) “Good Clinical Practice” Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by …