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 scientific and technical aspects of pharmaceutical development.
Through working groups of regulatory and industry experts, ICH produces harmonised technical requirements to ensure the development and registration of safe, effective, and high-quality medicines. Technical guidelines are developed through scientific consensus, with public consultation.
ICH Guidelines are adopted by regulatory authorities and published on the ICH website.
ICH also produces a standardised reference tool for medical terminology (MedDRA) in 27 languages and electronic standards for the transfer of regulatory information (ESTRI).
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 members, 43 observers and a network of close to 700 experts globally.
ICH’s mission is to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines.
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as an international association, a legal entity under Swiss law.
This step built upon a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development as well as their regulation, and a longer standing recognition of the need to harmonise.
By making information publically available, the ICH Assembly and its Management Committee hope to make the ICH process ever more transparent, so that all stakeholders can be informed on important decisions and real-time progress of ICH Guideline development.
The ICH Association is primarily funded by annual membership fees, with the ICH Assembly responsible for approving the Association’s annual budget and the amount of the fees, as well as other financial means to be raised for the next fiscal year.