RESEARCH RESOURCES. New EU legislation for clinical trials of medicinal products will be phased in over the coming years. All new applications must be submitted in accordance with the new regulation. The Swedish Medical Products Agency provides information on its website, and researchers can receive local support from the Research Support Office and Gothia Forum.
On January 31, 2022, the Clinical Trials Regulation (CTR) went into effect. CTR is a new EU regulation for clinical trials of medicinal products for human use (EU regulation no. 536/2014). It replaces national legislation and Directive 2001/20/EC on clinical trials of medicinal products with three-year transitional rules being applied:
- NEW APPLICATIONS After January 30, 2023, all new clinical trials applications must be submitted and completed in accordance with CTR.
- ONGOING CLINCIAL TRIALS Clinical trials already underway may continue under the legacy legislation but must be transferred to the EU regulation if not completed and reported before January 30, 2025. It is the sponsor’s responsibility to complete the application for transfer on time.
- TRANSFER OF ACTIVE CLINICAL TRIALS Beginning January 31, 2022, sponsors may transfer ongoing clinical trials.
The European Medicines Agency (EMA) uses a web portal and database, Clinical Trial Information System (CTIS), providing a paperless and integrated system that covers the lifecycle of a clinical trial.
For more information about the clinical trial regulation EU 536/2014, visit the Swedish Medical Products Agency’s website: Swedish Medical Products Agency
Find out about Gothia Forum’s information and seminar series on the new EU regulation here.
Send your questions to the Research Support Office: firstname.lastname@example.org
BY: RESEARCH SUPPORT OFFICE