New European clinical trial legislation is under way

Updated 03 August 2021

In January 2022, the new Clinical Trials Regulation will be implemented. Under the Regulation, all clinical trial applications for trials with medicinal products in humans will have to be applied through a new Clinical Trial Information System (CTIS) along with amendments and other changes to ongoing clinical trials. This is done to harmonise and streamline the processes for application and supervision of clinical trials throughout the EU. 

The Regulation will bring new requirements regarding application, deadlines, and communications with the competent authorities and ethics committees, and builds on the same central principles of good clinical practice as the current EU directive 2001/20/EF. The Clinical Trials Regulation can be found at the EU Commissions webpage along with their extensive Questions & Answers Document.

The new requirements regarding the application dossier are described in annex I of the Regulation.

The European Medicines Agency (EMA) offers support and training in the new CTIS portal. The training and support materials are available at their webpage.

We will update this page with questions and answers regarding the Clininical Trials Regulation.

Questions and answers on the Clinical Trials Regulation

The Clinical Trials Regulation applies to clinical trials of medicinal products for human use

  • Trials that will only take place in Denmark (Danish mono-national clinical trials, including trials from non-commercial sponsors), are they to be submitted through the EU portal?
    All clinical trials of medicines must be submitted via the EU portal. However, please see the information on the transition period in the first year.

  • Must all submissions take place via the portal, e.g. annual safety reports?
    All submissions throughout the term of the clinical trial, including notifications, substantial amendments, annual safety reports, final report and results must take place through the portal. SUSARs are an exception and must be submitted directly to the EudraVigilance database (however, we do not know the final solution yet).

  • When will the regulation enter into force/apply?
    The regulation will not enter into force before the EU portal that is to support the communication between sponsor/applicant and the authorities has been fully developed. The EMA's Management Board has confirmed that portal will go live by 31 January 2022.

  • How should I submit my application after the regulation has entered into force?
    You are to submit your application for authorisation of a clinical trial to the EU portal. You will no longer be required to submit applications directly to the national authorities. This includes the application to the Danish Medicines Agency as well as the application to the ethics committee. However, please see the information on the transition period in the first year.

  • How are ongoing national and VHP trials to be handled – is there a transitional arrangement?
    A transitional arrangement will apply, which makes it possible to submit applications under the old legislation for up to one year after the entry into force of the regulation. If an ongoing clinical trial has not been completed within three years after the regulation entered into force, the regulatory framework of the clinical trial must switch to the regulation. The European Commission has published a guideline on how to do this (please see section 11). This means that trials which are not concluded by 31 January 2025 have to be transferred to the regulation. If the trial is not transferred before this date, it will have to be stopped as it will be illegal to continue the trial.

  • How can I see which documents to submit?
    The regulation’s Annex 1 includes a list of the documents that must be submitted.
  • Will the Danish Medicines Agency keep us updated on the concrete changes in relation to applications for clinical trials of medicines?
    Yes. Once we know more about how the EU portal will look, we will be holding information meetings and post information on our website. Should it become possible to practice using the EU portal, we will keep you updated about this.
  • Which clinical trials are covered by the new legislation?
    The new legislation applies to clinical trials of medicinal products for human use.
  • Will I still have to submit my application to the Danish Medicines Agency and the Research Ethics Committee System after the regulation has entered into force?
    Your application for authorisation of a clinical trial will be reviewed by us and the Research Ethics Committee System when it is submitted to the new EU portal. Applications should therefore not be submitted directly to the Danish Medicines Agency or the Research Ethics Committee System. However, this only applies to clinical trials of medicines.
  • How should I report SUSARs?
    When the regulation enters into force, SUSARs are to be reported directly to EudraVigilance and thus not simultaneously to the participating national member states. We do not know the final solution yet. However, it is now clear that SUSARs from trials approved under the current EU directive 2001/20/EU can be reported to Eudravigilance as well, once the regulation enters into force. Therefore, SUSAR reports to the Danish Medicines Agency (DKMAEUDRA) will no longer be a requirement from that point onwards. The DKMA e-form will remain active.

Change log:

Updated on 03 August 2021 - Added text describing the Clinical Trials Regulation in the beginning, added box with external links to the right, and added details regarding the transistion period for ongoing trials.

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