Role Of ICH In Harmonising Drug Reulations

Abstract

The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. Harmonisation of regulatory requirements was initiated by the European Community (EC), in the 1980s, the EC moved towards the development of a single market for pharmaceuticals. ICH regulatory authorities are among the first to evaluate new chemical entities and new products obtained from biotechnology. ICH provides various guidelines which are categorised into four category, Quality guidelines, safety guidelines, efficacy guidelines and multidisciplinary guidelines. These guideline give special concern for the patient population, large-scale human clinical trials lasting up to one year can begin in the absence of completed carcinogenicity studies in rodents.