ICHn

ICHn refers to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, often shortened to ICH. It is a unique international project that brings together the regulatory authorities and the pharmaceutical industry in Europe, Japan, and the United States to discuss scientific and technical aspects of drug registration. The aim of ICH is to promote public health by making it easier to develop and register safe and effective new medicines. This is achieved through harmonization, which means reducing the need for additional clinical trials and testing in different regions, thereby speeding up the availability of new drugs to patients worldwide.

The ICH develops guidelines that address various stages of the pharmaceutical development process, including research and development, quality control, safety, efficacy, and multidisciplinary topics. These guidelines are developed through a consensus-building process involving experts from regulatory bodies and industry. Once adopted, the guidelines are implemented by the regulatory authorities of the ICH regions. The organization was established in 1990 and has since expanded its membership to include other regions. ICH guidelines are widely recognized and adopted globally, serving as a benchmark for pharmaceutical development and regulation.