Starting September 1, 2025, the Swedish Medical Products Agency (Läkemedelsverket) introduced a fast-track process for evaluating mononational clinical trial applications for medicinal products in the Clinical Trials Information System (CTIS).
This initiative aims to strengthen Sweden’s position as an attractive hub for Life Science research. With the new fast-track process, applications will be assessed within 26 days and approved within 30 days if complete and compliant.
Key points:
- Applies to trials planned exclusively in Sweden
- No pre-approval for fast track required
- Complete applications (Part I & II) are essential
This is a great step toward accelerating innovation and supporting sponsors in bringing new treatments to patients faster.
Learn more on the Swedish Medical Product Agency’s website.
Need support with your clinical trial application and submission? Contact our Aurevia CRO clinical trial experts at request.cro@aurevia.com.
