In order to ensure the protection of confidential information, in particular personal data of clinical trial subjects related to their health as well as commercially confidential information, the inspectors and experts involved in inspections should be bound by the highest standards of confidentiality and the applicable requirements of the Union law, national laws and international agreements.
Il est nécessaire d'abroger la directive 2005/28/CE de la Commission [3] afin de garantir qu'une seule série de règles s'applique aux inspections des bonnes pratiques cliniques relatives aux essais cliniques, y compris aux essais cliniques régis par la directive 2001/20/CE du Parlement européen et du Conseil [4].