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 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 …

You can explore in the below table the index of all ICH Guidelines, finalised or under development, on the topics of Quality, Safety, Efficacy and Multidisciplinary.

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 Administration and Units …

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 …

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

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 …

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 …