Regulation for Clinical Trials
On January 31, 2022, the new Clinical Trials Regulation came into force
Under the EU regulation on clinical trials with human medicinal products, all trials must be applied for in a common European system (CTIS). This means that all information about trials in the EU is collected in one place. For trials intended to be conducted in multiple countries, the relevant national authorities collaborate on the assessment. At the national level, the Danish Medicines Agency and ethical committees coordinate a joint decision.
A number of new initiatives regarding application, deadlines, and communication with authorities came into effect in connection with the regulation. The central principles from EU Directive 2001/20/EC on good clinical practice in the conduct of clinical trials are maintained. Likewise, a number of quality standards for the different phases of trials and for data management are retained.
If an ongoing trial is not completed within 3 years after the regulation comes into force, the trial must be transferred to the regulation. This means that trials not completed by January 31, 2025, must be transferred to the regulation. If the trial is not transferred by then, it must be halted, as it would otherwise be conducted illegally. Guidance on the transition arrangement can be found in Section 11 of the EU Commission's question/answer document.
Read more about the regulation here:
The regulation can be read on the EU Commission's website. Here is a direct link to the document.
The EU Commission's question/answer document is found under the header Set of documents applicable to clinical trials authorised under Regulation EU No 536/2014 in the updated EudraLex Volume 10 for the Regulation.
If trials are applied for under the regulation, they must be submitted via CTIS (Clinical Trial Information System). Responses to the application will also be received in CTIS. This means that all correspondence regarding an application will take place in CTIS, and sponsors must therefore be aware of deadlines and responses in CTIS. CTIS can be found at this link.
We encourage you to learn more about CTIS and participate in EMA's training programs. EMA offers ongoing training programs. The overview is updated on EMA's website. The link can be found here.
The GCP units' guides to CTIS are very user-friendly and can be found on their website.
The EU Commission has also prepared a quick guide for sponsors, describing the main principles of the regulation and the application for clinical trials. However, the Danish Medicines Agency recommends that you first consult the GCP units' guidance.
To support collaboration between the Scientific Ethical Medical Committees and the Danish Medicines Agency, the Act on Clinical Trials with Medicinal Products has been adopted and the Executive Order on Clinical Trials with Medicinal Products has been issued.
The Scientific Ethical Medical Committees have also created a Q&A page for CTR/CTIS, where they answer a wide range of questions about submission requirements.
Change Log
Updated June 11, 2024 - In connection with general website update. Reference is made to a separate tab for questions/answers.