Clinical Trial Regulation:
A New Chapter for EU Clinical Trials
In Collaboration with FGK.
Authors:
FGK
Dr Uwe Kramer
Scendea
Amy Cooke & Dr Maria Beatrice Panico
What is The Clinical Trial Regulation?
The “Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC”, in short, the Clinical Trials Regulation (CTR), regulates interventional clinical trials in EU Member States and European Economic Area (EEA) countries.
The CTR replaces Directive 2001/20/EC, the first EU-wide legislation for clinical trials of medicinal products which applied from 01 May 2004. In the EU, legal texts called “directives” are not immediately applicable. Directives define a framework of rules that come into force only after implementation into national law….