Regulatory networks have gotten off to a good start
ATMP Denmark's two regulatory networks for public stakeholders and companies have now held their first meetings. The networks are intended to create space for knowledge sharing and exchange of experience on regulatory issues.
- Regulatory
- ATMP
At the meeting for public stakeholders, the focus was on:
Better overview of 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 framework
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-intensive.
Regulatory 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.
At the meeting for private stakeholders, the focus was on:
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 pointed to the need for more consistent requirements in Europe to provide better opportunities to navigate globally.
The potential of ATMPs requires better frameworks
Participants highlighted 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.