Impactful EU Clinical Trial Regulation Changes

ACT: What are the most impactful changes that companies need to be aware of?

Neuberger: It was a different regulatory framework. Regulation is something is directly applicable in the member states, so no national translation into national law anymore. Member states basically follow the same procedures, processes, timelines, and have only one overall framework. It also means new terminology. You have a reporting state. First, you have to choose your reporting member state. Next, you have a completely new technical solution, which was the gateway, which is the clinical trial information system or in short, CTS. With this, we have a common language and documentation that is split into two parts. Part one is the core documentation, and part two is the patient facing local documentation. Now, we are also having an overview of clinical trials in the EU clinical trial register, which is a World Health Organization listing. Primary registry information on the clinical trials is now also being published. This is where the transparency rules come in. Now you have a very complex process, and the preparation for submitting a clinical trial takes longer than it did before.

We are now in for very tight timelines. For instance, the timelines for response to questions from the Health Authority is 12 days, and that is calendar days, not working days. There’s much more coordination of the processes involved, you have more parties involved, and you have to make sure that you involve all the other platforms that you have across the European Union. Even though it's one common framework, there are still some member state specific requirements, because obviously that had to stay.