How to Apply for Clinical Trials with Medicinal Products in Denmark and Europe

Under the EU regulation on clinical trials with human medicines (CTR), all trials must be applied for in a common European system (Clinical Trial Information System (CTIS)). This means that all information about trials in the EU is gathered in one place. For trials that are to be conducted in multiple countries, the authorities of the involved countries collaborate on the assessment. At the national level, the Danish Medicines Agency and ethical committees collaborate on a joint decision.

A number of new rules regarding application, deadlines and communication with the authorities came into force with the regulation. Compliance with good clinical practice (ICH GCP) remains unchanged, as do most quality standards for the various trial phases and data handling.

Processing Times

The Clinical Trials Regulation (CTR) sets a fixed framework for processing times, and these rules are built into CTIS. Therefore, it is not possible for either applicants or authorities to exceed the deadlines set by CTR. If the applicant misses a deadline, the application process must start over again; if the authorities miss a deadline, the process moves on to the next step.

The Danish Medicines Agency and the Medical Research Ethics Committees (MREC) collaborate to continuously optimize work processes to ensure the best possible assessment/processing times. We prioritize fast assessment of all mononational trials in Denmark. The goal is that a valid mononational trial will be assessed no later than day 26 (calendar days). If there is no missing information and the trial can be approved, the decision will be given no later than day 31 (calendar days). For early-phase trials, the goal is to offer particularly fast response times and is a special focus area in 2025.

Here you can read more about the regulation:

The regulation can be read on the EU Commission’s website.

The EU Commission’s Q&A document can be found under the heading “Set of documents applicable to clinical trials authorized under Regulation EU No 536/2014” in the updated EudraLex Volume 10 for the regulation.

When applying for clinical trials an application must be submitted via CTIS (Clinical Trial Information System). You will also receive responses to the application in CTIS. This means that all correspondence regarding an application will take place in CTIS, and sponsors must therefore be aware of deadlines and new tasks in CTIS. Note that CTIS does not send email notifications.

It is the sponsor’s/applicant’s responsibility to keep track of deadlines in CTIS and submit responses to questions on time. If the sponsor fails to respond or provides an insufficient response, the application may be rejected. We strive to offer an additional round of questions (2. round of RFI) if possible within the CTIS timeframe for the trial.

CTIS can be found via this link.

We encourage you to read more about CTIS and participate in EMA’s training programs. EMA offers ongoing training programs. The overview is updated on EMA’s website. You can find the link here.

The GCP units’ guidelines for CTIS are very user-friendly and can be found here on their website (in Danish only).

The EU Commission has also prepared a quick-guide for sponsors, which describes the main principles of the regulation and the application for clinical trials. However, the Danish Medicines Agency recommends that you first familiarize yourself with the GCP units’ guidelines.

To support the collaboration between the Medical Research Ethics Committees and the Danish Medicines Agency, the Act on Clinical Trials with Medicines and the Executive Order on Clinical Trials with Medicines have been adopted.

The Medical Research Ethics Committees have also created a Q&A page for CTR/CTIS, where they answer a wide range of questions about submission requirements.