Fees for clinical trials

Executive orders regulating fees for clinical trials with medicinal products

The fees for clinical trials with medicinal products cover the costs associated with the assessment of applications by the Danish Medicines Agency (DKMA) and the Danish Medical Ethics Committees (VMK), as well as ongoing monitoring of the trials. 

The fees are determined according to both the regulation on clinical trials  (CTR) and the Danish Medicines Act.
For new trial applications and changes under the regulation (processed in the Clinical Trials Information System - CTIS), a single invoice is issued covering the fees for both DKMA and VMK.

Applicable fees as of January 11, 2024

As of January 11, 2024, fees are reintroduced for clinical trials with medicinal products that are conducted entirely or predominantly without influence from pharmaceutical companies (non-commercial trials)* and for commercial phase I trials.

Non-commercial clinical trials are exempt from fees for initial applications and substantial modification requests to DKMA, and fees are only charged for the processing by VMK. In addition, the annual fee to DKMA is halved for non-commercial sponsors.

Annual fees are invoiced twice a year. New trial applications approved in the first half (Jan-Jun) are invoiced by the end of March of the following year, while applications approved in the second half (Jul-Dec) are invoiced by the end of September of the following year. All clinical trials will be invoiced for the first time in the following year based on the above cutoff dates.

If a commercial applicant submits an Investigational Medicinal Product Dossier (IMPD), the fee is charged according to column "B" in the table below. If the applicant believes that a fee should be charged according to column "A" the applicant is expected to provide a justification in the cover letter accompanying the application.

The fee overview for 2024 can be found here (only in Danish)

*"conducted entirely or predominantly without influence from pharmaceutical companies," means: Investigator-initiated trials where pharmaceutical companies have no influence on the trial's design, initiation, conduct, and the registration and publication of trial results.

Payment and invoice information

Fees must be paid to the Danish Medicines Agency within 1 month of receiving the invoice. Billing information must be provided in the cover letter to the application or in the "proof of payment" section in CTIS. For public entities, the EAN number must be provided. If invoices need to include specific information, such as references like PO numbers or contact persons, this should be indicated in the billing information. An exception is the invoicing of annual fees, where it is not possible to include specific information. Here only the EudraCT or CT number will appear on the invoice.

Who do we invoice the fees to?

If specific billing information is not provided for initial applications and substantial modification requests, the applicant (according to EudraCT) under the directive is invoiced by default, whereas for submissions in CTIS under the regulation, the designated sponsor is invoiced.

It is not possible to define separately who should be invoiced the annual fee for the clinical trial. Annual fees are always invoiced to the same debtor who was invoiced for the fee at the initial submission.