International Council for Harmonisation [ICH]

Formerly the International Conference on Harmonisation. The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) produces harmonised guidelines for global pharmaceutical development, and their regulation. It brings together the regulatory authorities and the pharmaceutical industry from five regions (Europe, Japan, USA, Canada and Switzerland).

ICH has been established in order to reduce the duplication of clinical trials and create a more streamlined regulatory assessment process for new applications. As such, ICH has developed four sets of guidelines provided for specific topics including quality, safety, efficacy and multidisciplinary (e.g. ICH medical terminology (MedDRA), or the Common Technical Document (CTD)) which are implemented by the regulatory authorities of its membership.

Glossary: Investigator’s Brochure [IB]
Glossary: Audit
Glossary: Good Clinical Practice [GCP]
Non-clinical development: Basic principles
Non-clinical studies can be performed at any time during the life-cycle of the product, testing the compound outside of humans. Non-clinical studies aim to identify candidate therapies with the greatest probability of success, assess safety, and build solid scientific foundations before the transition to clinical development phases.
Making a medicine. Step 9: Regulatory submission
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory authorities. The regulatory authorities then decide whether or not a medicine can be prescribed to patients.

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International Council for Harmonisation [ICH]

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