Glossary of Terms

International Conference on Harmonization (ICH)

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GCP: Good Clinical Practice

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use or ICH is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development. The mission of the ICH is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.  The ICH has produced guidelines and standards that are recognized and implemented by regulatory authorities around the world. Some successes of the ICH include the development of Good Clinical Practice (GCP), Common Technical Document (CTD), and Medical Dictionary for Regulatory Activities (MedDRA). In addition, they have over 60 guidelines that govern safety, quality, efficacy and multidisciplinary aspects of pharmaceutical product development.