International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a collaborative initiative involving regulatory authorities and the pharmaceutical industry. Established in 1990 by the EU, US, and Japan, and reformed in 2015 as a non-profit under Swiss Law, its goal is to harmonize technical requirements for drug development across these major markets.

The aim of the ICH is to improve the efficiency of drug development and registration processes, reduce redundant clinical trials, improve the design and manufacture of new medicines, and minimize animal testing without compromising safety. This is achieved through the development of technical guidelines and standards that are implemented by regulatory authorities.

The association includes regulatory members like the European Commission, US. Food and Drug Administration, and Japanese Ministry of Health, Labor, and Welfare, industry members, and observers such as the World Health Organization. ICH has developed 77 guidelines (as of November 2024) covering quality, safety, efficacy, and multidisciplinary topics.

Notable ICH products include the Common Technical Document (CTD), electronic standards for regulatory information transfer, and the Medical Dictionary for Regulatory Activities (MedDRA). The ICH governance structure comprises an Assembly and a Management Committee, with guidelines developed through working groups. The ICH process for guideline development involves five steps, and regulatory authorities are expected to implement these guidelines upon adoption. The ICH Assembly meets biannually to oversee and adopt new guidelines.