On 31st January 2022, the new EU Clinical Trials Regulation 536/2014 (CTR) entered into force and began a three-year transition period. In just a couple of months’ time, on 31st January 2025, it will finally replace the existing Directive 2001/20/EC (CTD). The new EU-CTR aims to overcome the limitations of EU-CTD and to increase the EU’s competitiveness in the drug development market. Here we explain a few of the key differences between the two.
Why was the new regulation necessary?
The EU-CTD has governed clinical trials within the EU since 2004, by standardising processes and thus enhancing patient protection. However, because it was a directive, it has never carried the same mandatory weight as a regulation. This manifested in all EU member states having to implement its legal requirements through its own legislation. Therefore, sponsors and others have faced a fragmented assessment process for multinational clinical trial applications, as well as a complex data submission framework. Moreover, the public has had limited access to clinical trial applications and results.
As a regulation, the new EU-CTR is binding on all EU member states in its entirety, a key difference from the EU-CTD. It seeks to increase transparency and restore the EU’s clinical research competitiveness, by reducing administrative requisites and streamlining workflows. The hope is that it may help reinvigorate clinical research in Europe.
The Clinical Trials Information System
One of the key developments of the new regulation is the creation of the Clinical Trials Information System (CTIS). This new single system, enables sponsors to submit one online application to run a clinical trial in several European countries, making it more efficient to carry out multinational trials. The system also allows EU member states to evaluate and authorise such applications all together, therefore with much more efficacy for all parties.
Other main differences
Another key difference of using the new CTIS, is the increased public transparency that it allows. The EU-CTR makes all data and documents in the CTIS publicly available, throughout the whole development process, with only some exceptions (for example, for patient confidentiality).
There are also new, much shorter, timelines that have to be adhered to. Sponsors now have only 12 calendar days maximum to respond to application queries or requests for information. Otherwise, applications will lapse by default. This, along with some other strict timelines should push sponsors and CRO teams to think ahead and plan carefully.
There is also simplified safety reporting and improved patient protection for vulnerable people, all of which should help facilitate the conduct of more clinical trials in multiple EU member states and EEA countries.
How can we help?
It’s clear that the introduction of the EU-CTR should increase the EU’s competitiveness in the drug development market, however there is still much detail in the new regulation that sponsors need to be very aware of, for example and as mentioned, the stricter transparency and reporting obligations, new safety and patient protection provisions, updated definitions and shorter deadlines. Communication with regulatory and regulatory intelligence teams will be valuable, as the new regulation encourages sponsors to think more proactively and more frequently about their regulatory strategy. That’s where Insife’s unique service GRIP could help.
GRIP, the Global Regulatory Intelligence Club for Pharmacovigilance, helps pharma companies and biotechs, big and small, as well as CROs, by taking on the work of tracking changes in global regulation. It’s a one-of-a-kind subscription service consisting of a comprehensive collection of global requirements, that have been collected and analyzed by our pharmacovigilance experts. The team consistently assesses and interprets changes in legislation and finds the relevant new information for the GRIP members, taking that time consuming, but vital, job out of their hands.
If you have any questions or would like to discuss how GRIP could help your team, please don’t hesitate to contact us at hello@insife.com.