GCP and Quality in “Regulation (EU) 536/2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EU”

Abstract

Among the several new provisions foreseen by the EU Regulation (R) 2014/536 on Clinical Trials (CTs) repealing Directive (D) 2001/20/EC, this article focuses on the identification of possible critical points leading to potential incongruences regarding Good Clinical Practice (GCP). EU D foresees the obligation to be in compliance with GCP detailed guidelines, while the R foresees the obligation to be in compliance only with the GCP principles. Many of the GCP detailed aspects have been transposed in the R and the R provides to be in compliance with GCP quality standards. Nevertheless, other GCP aspects, which have direct or indirect ethical implication in CTs, will not be mandatory in the EU.