Clinical trials of medicines
The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20th 2022.
The Danish Medicines Agency is closed for the Holiday Season, from December 24th, 2022, until January 1st, 2023, both days included.
Applications concerning marketing authorisations and clinical trials need to be submitted before December 20th, 2022. We will consider applications submitted after December 20th, 2022, as if they have been received January 2nd 2023.
For applications concerning clinical trials, please note that the EU Clinical Trials Directive expires on January 31st, 2023. After this date, all applications will have to be applied through the new Clinical Trial Information System (CTIS) under the EU Clinical Trials Regulation. For more information see our webpage regarding the Regulation.
For applications concerning clinical trials applied under the Clinical Trials Regulation no assessment will be performed during the winter clock stop between December 22nd ,2022 and January 6th, 2023, both days included. The deadlines for these trials are postponed.
Well-designed and safe clinical trials help us acquire knowledge about medicines and give us the opportunity to achieve new, effective and safe medicines and are central to the authorisation basis of medicines. Clinical trials are essential to an attractive and competent environment for pharmaceutical development and research in Denmark. Clinical trials help develop the competencies of healthcare professionals as it gives them early insights into new treatment forms and medicines, and this is of direct benefit to patients who gain access to the newest medicines faster. The Clinical Trials unit is working diligently to establish a safe framework for clinical trials through discussions with stakeholders and the EU for the benefit of patients.
Our focus is to ensure a timely review of a high standard while developing guidelines that support the conduct of tomorrow’s clinical trials. Together with the other players in the Danish clinical trial ecosystem, we strive to put the patient at the core of research by involving their perspectives so that together we can position Denmark firmly in Europe when it comes to the future’s methods and innovation within clinical research such as decentralised clinical trials.
If you would like to know more about clinical trials, please visit this page: Clinical trials of medicinal products.
We want Denmark to be in the lead in early phase research
We have strong capacities throughout all stages of medicines development, but we believe that Denmark has the prerequisites to excel, in particular, in the development of new trial designs, complex clinical trials of medicines related to rare diseases or individual medication, as well as in research in the early development phases, including first in human (FIH) trials. This is primarily owing to Denmark’s skilful and specialised researchers as well as Denmark’s many technological opportunities.
This focus gives Danish patients access to the newest treatment forms and builds up the knowledge capacity of both authorities and researchers, with gains to be made also in the later stages of pharmaceutical development.
We are continuously working on projects to support early research, and this is reflected in our objectives for our review times for first in human (FIH) trials. We also have strong competencies to support the transition from toxicology studies to clinical trials and offer scientific advice on toxicology, clinical and regulatory questions.
In 2021, the time for reviewing FIH trials has been adjusted downwards to only 14 calendar days
This applies to both the initial application and subsequent requests for substantial amendments. In addition, we have organised our processes to ensure as far as possible that submissions regarding the same FIH trial are coordinated by the same administrative officer to maintain continuity and good collaboration with the applicant.
Intensified preparations for the new European legislation
As from December 2021, clinical trials will be governed by a new European regulation which centralises the review of clinical trial applications, resulting in many administrative changes. We are fully engaged in the preparation thereof, and we will provide many more updates about this. You can stay updated on this page: New European clinical trial legislation is under way.
Danish experience makes a difference in Europe
Our vision becomes reality through active participation in influential working groups under the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) and more. In these setups, we ensure that Danish knowledge and tools are implemented widely in Europe for the benefit of patients and society.
Right now, we are focusing especially on the development of complex trial designs and decentralised clinical trials. You can read more about this work in existing and coming theme pages.