Through working groups of international regulatory and industry experts, ICH produces harmonised guidelines to support the development and registration of safe, effective and high-quality medicines around the world.
These technical guidelines are developed collaboratively and normally represent a scientific consensus. They are finalised following extensive public and regulatory consultation, approved by ICH’s regulatory members, and then adopted and implemented by regulatory authorities.
New topics for future harmonisation are proposed and discussed regularly.
A highly specific standardised medical terminology used for registration, reporting and safety monitoring of medical products.
Electronic Standards for the Transfer of Regulatory Information for secure transmission, standardised formats and interoperability.
The Common Technical Document, a standardised core dossier format for submitting information to regulators.
Technology Task Force, exploring the development of a digital platform to accelerate harmonisation.
Your search for specific guidelines starts here. Use the search bar and the filters below to navigate the database of documents produced by ICH.
At Step 5 of the ICH process, harmonised ICH guidelines are implemented by ICH Regulatory Members and Observers within their respective country/region.
Learn more about the implementation status of each ICH harmonised guideline.
