Role of ICH in Harmonising Drug Regulation

International council for harmonization of technical requirements for pharmaceuticals for human use (ICH) is a joint initiative founded to collaborate regulatory authorities with the authorities of industries for taking part in scientific and technical discussions of testing procedures that help in ensuring efficacy and safety of the medications.The major contribution in developing ICH guidelines was by the regulatory and industrial authorities of Europe, Japan and the United States.Many other countries also have now joined hands with them to harmonise drug regulation worldwide.ICH has made very remarkable progress since its initiation.Most of the guidelines were implemented and maintained since the first ten years and thus they hold a solid foot without drifting between regions using the guidelines, which evidently shows why ICH still stands intact.ICH provides guidelines for quality, safety, efficacy and multidisciplinary aspects.This article will review the history, need for harmonisation, initiation and establishment of ICH, objectives, process of harmonisation, associated organisations and the guidelines.