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New EU Clinical Trials Regulation

The European Union has had a decline in the number of clinical trials and clinical trial applications since 2007. This trend has largely been attributed to the complicated application process which required a different application and review process for each country where a trial would have sites. In order to increase innovation and increase the number of applications, the EU has enacted a new clinical trial regulation to simplify the process.

There will be a transition period where the old application can be used but beginning in January 2023, all new submissions must be submitted under the new regulator infrastructure, and all ongoing studies have until January 2025 to either complete or convert to the new regulation.

Previous Directive

The implementation of EU clinical trials directive 2001/20/EC (EU-CTD) created unintended challenges and did not carry much weight as it was it not a regulation. Because of this, each EU state had to implement its own legal requirements, causing sponsors to have a fragmented assessment process when submitting multination applications. Furthermore, the public had little access to clinical trial applications and results in the EU.

New Regulations

The failures of the previous directive led to the development of a new regulation, CT Regulation 536/2014 (EU-CTR), which became binding to all EU members effective January 31, 2022. This regulation aims to harmonize and simplify the clinical trial process in the EU by focusing on decreasing administrative requirements to streamline the workflow, thereby increasing transparency and competitiveness of clinical trials in Europe.

Key Changes

While the information for applications remains the same, the submission process has been simplified to coordinate the assessment of applications involving multiple nations. Specifically, the sponsor of the study will only have to submit one clinical trial request that is addressed to all the countries where the trial will occur. A single country, proposed by the Sponsor or another country that wants to the Reference Country, will then complete the evaluation of the national or multinational trial. This Reference Member State will coordinate and direct the joint evaluation process and will be the only one in contact with the Sponsor. A single opinion will then be issues and become binding for all the countries where the trial will be carried out.

Additionally, there will be one centralized electronic database which will allow for management of all documentation and communications between the sponsor and the participating countries to occur in one portal.

To increase public transparency, an EU database was created and will house all documents and information related to the trial. This is open to the public, except for any personal study data related to subjects and any confidential information related to different countries or member states. This change allows anyone to search and research clinical trials.

It’s important to note that all the planning for a trial will need to be done in one phase, with two parts of the submission process. Part one will have all the study content (the scientific and medicinal documentation related to the Clinical Trial) and Part two will be all the country and site content (local regulatory aspects of the specific country, including patients). This simplifies the process. that in the past could amount to 100+ submissions, to just two but does have the caveat that these are now fixed. Specifically, adding a new site will become a substantial amendment under the new regulation, and are not allowed to be submitted while the initial or previous substantial amendments are under review. Therefore, new sites can only be added four times a year under the new regulation because the approval process takes 90 to 105 days, meaning there will need to be more planning and coordination at startup.

In May, the EU also released a document answering frequently asked questions for complex clinical trials as an additional resource in understanding the new regulation.

How this benefits MEDSIR

At MEDSIR, many of our trials are multinational, therefore the new regulations will provide a more streamlined process to keep us agile and competitive in the clinical research environment. We hope that this new regulation will help to make us even faster in recruitment numbers, have quicker responses in a public health crisis, and increase EU data in marketing authorization applications.

If you have questions about the new regulation or about any of our multinational trials, please contact us! Also watch this video for a great summary of the what’s new for clinical trials in the EU!



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