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

摘要

AbstractAmong 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.Highlights?The importance of the Good Clinical Practice in the conduction of a clinical trial?The EU Regulation (R) No. 536/2014 and its compliance with the GCP?Differences between the EU Regulation (R) No. 536/2014 and the current legislation?