Regulatory support
ATMP Denmark offers regulatory support to public and private stakeholders working with ATMPs in Denmark.
What can you expect?
Development of advanced therapies requires early regulatory clarification. What requirements apply? Which authorities need to be involved? What needs to be in place before a clinical trial can begin?
ATMP Denmark offers non-binding regulatory guidance to public and private stakeholders working on the development or clinical trials of ATMPs in Denmark.
We are not a regulatory authority and cannot make decisions or assess data. That responsibility lies with the relevant authorities. In return, we can help you gain an overview of the process, identify regulatory issues, and find the right points of contact.
You can get help with:
Clarification of regulatory questions in your specific project (e.g. approval process, requirements, and expectations for documentation).
Which requirements for later commercialisation and clinical implementation should be considered already in the early phase.
Preparation for dialogue with regulatory authorities, including which questions are important to clarify early on, and what you may benefit from having ready.
We will do our best to answer your question.
Who can receive regulatory support?
We collaborate with both public and private stakeholders in Denmark—and provide guidance and support regarding ATMP.
Public hospitals
Academic environments
Private companies
How we help you move forward
Send an email to regulatorysupport@atmp.dk with a brief description of your project. We will confirm receipt and get back to you with suggestions for next steps, which may be a short clarifying meeting or a written summary.
The network for public actors
At the first meeting of the regulatory network for public stakeholders, the focus was on experiences and challenges across the organizations working with ATMPs. The discussions centered on five main points:
Better overview on the path from research to treatment
At the meeting, there was a call for a clearer overview of the regulatory requirements – from early development and clinical testing to approval and clinical implementation.N-of-1 treatments challenge the existing frameworks
Individually tailored treatments hold potential for patients with rare diseases, but participants pointed to the need for greater clarity about the path to treatment and the subsequent follow-up.Experience from CAR-T shows the need for better coordination of requirements
Clinical departments must handle requirements from both authorities and companies, including certification and follow-up. At the meeting, there was a call for more consistent handling and better coordination so that implementation becomes less resource-intensiveRegulatory expertise must be close to research and clinical practice
Easy access to practice-oriented regulatory sparring and stronger expertise in hospitals were highlighted as key needs to support the development and clinical implementation of advanced therapies.
Network for companies
At the first meeting of the regulatory network for companies, participants shared experiences with the regulatory challenges they encounter in working with ATMPs. The discussions centered on five main points:
Early regulatory advice is crucial
Participants called for better frameworks for faster access to concrete, phase-based guidance so that uncertainty about documentation requirements and product changes does not slow the development of new ATMPs.Greater harmonization should support development across borders
Differences in regulatory requirements and interpretations create challenges. The meeting highlighted the need for more consistent requirements in Europe to provide better opportunities to navigate globally.The potential of ATMPs requires better frameworks
Participants emphasized the potential of ATMPs to meet unmet treatment needs, but also the challenges related to financing and scaling up production, which must be addressed if that potential is to reach patients.Need for clarity on the transition to the new SoHO rules
Participants called for greater clarity on the Danish implementation and the transitional rules – including the implications for cells and tissues already collected.
