Denmark's single point of entry for advanced therapy medicinal products
We are working to establish a single coordinated point of entry for ATMP in Denmark, so Danish patients gain early access to new treatments.
Towards a sustainable organization of ATMP Denmark
ATMP Denmark originates from the government’s Life Science strategy and was established by Ministry of Health and Ecclesiastical Affairs of Denmark, Danish Regions and Amgros. The Secretariat is anchored in Amgros.
The Secretariat coordinates the work, while the steering group sets the strategic direction. The reference group ensures anchoring in clinical practice and research.
ATMP Denmark is organized as a program from 2024 to 2027 with a focus on developing and establishing a single point of entry to the ATMP field in Denmark. The goal is to identify a sustainable organization for ATMP Denmark after 2027.
Denmark in numbers
Denmark is number three in Europe when it comes to the speed from EU approval to patients' access to new medicine.
ATMPs are recommended by the Danish Medicines Council for 13 different patient groups in Denmark.
6.7 clinical trials per million inhabitants. Denmark ranks number 2 in Europe for clinical trials within advanced therapy medicinal products.
Together we build health
From collaboration and advisory services to analysis and networking—our efforts are divided into four tracks that bring new treatments closer to patients.
Denmark is well positioned to advance the development of advanced therapies. We have a solid life science sector, leading research environments at hospitals and universities, and a proven track record of collaboration across diverse stakeholders within a complex healthcare system. This is already evident in the fact that Denmark is among the leading European countries in terms of the number of clinical trials conducted per capita.
Cancer treatment paves the way for new therapies
CAR-T therapy is already used for selected forms of blood cancer. The treatment involves changing the patient’s own immune cells so that they can better recognize and attack diseased cells.
Now researchers are investigating whether the technology can also be used for selected, difficult autoimmune diseases such as systemic lupus and multiple sclerosis. In autoimmune diseases, the immune system attacks the body’s own cells, and therefore a targeted treatment of the immune system may be relevant for some patients.
Research is also underway into whether CAR-T can be used for other diseases in which the immune system plays an important role, and whether the treatment in the long term can be expanded to other types of cancer beyond blood cancer.
Commercial CAR-T treatment is provided to Danish patients in clinical trials or as standard treatment. Currently, treatments take place here: | Academic development and research in CAR-T treatment primarily takes place here: | ||
Many stakeholders contribute to the work of ATMP Denmark
ATMP Denmark collaborates broadly with both regions, universities, the pharmaceutical industry, and relevant authorities. We have organized the collaboration so that it consists of a steering committee, a reference group, a secretariat, and working groups.
In addition to setting the strategic direction, the steering committee also formulates objectives and decides whether analyses and pilot projects should be initiated. The group helps ensure progress in the activities that have been launched and supports collaboration within the ATMP area.
Three types
ATMP stands for Advanced Therapy Medicinal Products and is also referred to as advanced therapies. These are medicines based on genes, cells, or tissue that can repair, replace, or modify biological functions in the body.
From August 1st: Get help navigating the regulatory landscape
We offer regulatory guidance that can help researchers and clinicians, as well as companies, create an overview of the regulatory requirements in connection with the development and implementation of ATMP products. In addition, we establish and run national regulatory networks intended to promote knowledge sharing, dialogue, and a shared understanding of the requirements for the development and clinical testing of ATMPs.
Write to us - we will get back
We handle all inquiries confidentially. Send us an email and briefly tell us what you would like to clarify, and we will arrange the next step.
