GCP Harmonization In Developing Countries

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki. The International Conference on Harmonization was established in 1990 comprising of 17 countries. The main objective of ICH GCP Guidelines is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.