CIOMS Publishes Updated Glossary of ICH Terms and Definitions
The Council for International Organizations of Medical Sciences (CIOMS) has published Version 10 of the Glossary of ICH Terms and Definitions, a cumulative reference document that compiles terms and definitions from current guidelines and Q&A documents issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The glossary aims to provide a centralised source of terminology used across ICH Quality, Safety, Efficacy and Multidisciplinary guidelines, supporting consistent interpretation and communication of regulatory concepts.
A Centralised Reference for ICH Terminology
According to CIOMS, the glossary brings together definitions extracted from publicly available ICH guidelines, including both Step 2 draft documents and Step 4 final guidelines. The publication also incorporates relevant terms identified throughout guideline texts where formal definitions are provided.
The organisation notes that the glossary includes only definitions from the current versions of ICH documents and is intended as a practical reference tool for users working with ICH requirements.
Coverage Across Multiple Regulatory Areas
The glossary compiles terminology from a broad range of ICH guidelines covering areas such as:
Quality;
Safety;
Efficacy;
Multidisciplinary topics.
The publication includes terms relating to clinical trials, pharmacovigilance, manufacturing, quality management, bioanalytical methods, real-world data, data governance, electronic regulatory submissions and other areas addressed within ICH guidance documents.
Supporting Consistency and Harmonisation
CIOMS explains that the glossary was developed to facilitate access to ICH terminology and support the broader harmonisation objectives of the ICH.
The publication highlights that the ICH mission is to promote global harmonisation to ensure that safe, effective and high-quality medicines are developed and registered in the most resource-efficient manner.
By consolidating terminology from multiple guidelines into a single resource, the glossary may help stakeholders navigate complex regulatory concepts more efficiently and support consistent use of definitions across regulatory activities.
Updates Included in Version 10
Version 10 incorporates definitions from newly issued and updated ICH guidelines available as of 15 June 2026. New entries are identified throughout the glossary and reflect developments across multiple guideline areas, including clinical research, quality systems, real-world data and pharmaceutical development.
The glossary also includes a guideline index identifying the source documents from which definitions have been compiled and indicating newly added content.
Relevance for Medical Device and IVD Manufacturers
Although the glossary is based on ICH pharmaceutical guidelines, several topics included in the publication are also relevant for medical device and IVD manufacturers operating in regulated environments.
Examples include terminology associated with:
Data integrity;
Data governance;
Risk management;
Clinical investigations;
Real-world data;
Electronic regulatory information exchange;
Quality management systems.
For organisations involved in combination products, software-based technologies, digital health solutions or global regulatory activities, the glossary may serve as a useful reference for understanding terminology used across internationally harmonised regulatory frameworks.
