Good clinical practice compliance

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Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting clinical trials.

For clinical trials of veterinary products, the Europe Union has adopted the VICH GCP guideline, which provides guidance on the design and conduct of all clinical studies of veterinary medicines in the target species. The Committee for Veterinary Medicinal Products (CVMP) adopted the guideline in July 2000. It came into effect in July 2001. 

The guideline is directed at all individuals and organisations involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in target species. It is intended to make sure that these studies are conducted and documented in accordance with the principles of GCP.

The Annex to Directive 2001/82/EC, as amended, sets out conditions for the conduct of clinical trials included in marketing-authorisation applications.

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Contact point:

gcp@ema.europa.eu