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International Conference on Harmonisation (ICH)

The International Conference on Harmonisation of Technical Requirements for Registrations of Pharmaceuticals for Human Use (ICH) was established in 1990 by the FDA, the European Commission, and the Japanese Ministry of Health, Labour and Welfare (MHLW), as well as the industry associations of USA, Europe, and Japan. In the ICH, experts from industry associations and authorities work together with the aim of eliminating differences regarding the technical requirements for drug development in the three large pharmaceutical markets EU, Japan, and the USA. Since then, a large number of harmonised ICH guidelines concerning quality and safety of medicinal products, preclinical and clinical requirements, as well as multidisciplinary issues (e.g. medical terminology or electronic standards for the transfer of information) have been elaborated and implemented in the participating states. One of the achievements of the ICH is the Common Technical Document (CTD) with which a harmonised dossier has been provided for Europe, Japan, and the USA for transmission of data to the corresponding licensing authorities. Since the ICH was established, experts from the BfArM have been actively participating in various ICH Expert Working Groups.

For further information please refer to the Seiten der ICH.