International conference on harmonisation

The International Conference on Harmonisation (ICH) is an association of international authorities and was founded in 1990 by the FDA, the European Commission and the Japanese Ministry of Health with the participation of American, European and Japanese manufacturers' associations. The aim of the International Conference on Harmonisation is to eliminate differences in the technical requirements for drug development and to ensure equal safety and ethical conditions in all countries.

Since its foundation, the International Conference on Harmonisation has established numerous guidelines in the areas of quality (12 quality guidelines) and safety (10 safety guidelines) of medicinal products, preclinical and clinical requirements and standards for medical terminology and information transfer (electronic standards). The International Conference on Harmonisation has also drawn up several guidelines for clinical trials (18 efficiency guidelines). The overriding goal here is to harmonize regulations / standards and to achieve mutual acceptance of clinical data from studies already conducted by the regulatory authorities of other countries in order to avoid redundant work.

The most important ICH guideline is ICH Guideline E6 from 1996, the Good Clinical Practise (GCP). ICH guidelines are internationally recognized and are developed in cooperation with associations such as the World Health Organization (WHO).

In addition to producing guidelines, ICH has also created MedDRA (coding system for clinical trials) and CTD (Common Technical Document) and offers training courses on many topics.