EU Clinical Trial Regulation: What Does it Aim to Achieve?
In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, discusses the goals of the EU clinical trial regulation.
ACT: What does the EU’s clinical trial regulation aim to achieve?
Neuberger: That is an important part. Why are we where we are? I think when talking about clinical trial regulation, it is important to remember that we're talking about the framework under which 27 countries agreed to. Until January 2022, we had the old regulatory framework, and that was a clinical trials directive. The nature of the directive is that it needs to be translated into national law. This resulted in 27 local law or legislations, 27 timelines, 27 procedures, at least 27 procedures, member state specific things really diverging quality across the European Union with regards to the clinical trials. That resulted in a lack of oversight in clinical trials. So, it was 27 clinical trials instead of one. That’s why the member states were trying to harmonize clinical trial requirements, timelines, and procedures if you had a multistage trial. That was where we came in with regulation, and this is how we made it to the current regulation.
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