5 Further EU CTR 536/2014 Support
EU CTR 536/2014 refers to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, which governs the conduct of clinical trials in the European Union (EU). This regulation aims to streamline and harmonize the processes for conducting clinical trials across EU member states. Overall, EU CTR aims to improve the efficiency, transparency, and safety of clinical trials conducted in the EU, facilitating the development and authorization of new medicinal products for human use.
Between January 2022 and January 2023, new trial applications could follow either the old Clinical Trial Directive (CTD) requirements or the new Clinical Trial Regulation (CTR) requirements. However, from January 31, 2023, submission according to the CTR became mandatory and by January 31, 2025, all ongoing trials approved under the legacy CTD need to transition to the new regulation. All new trials in locations in scope for EU CTR must use CTR.
ClearTrial reviews and updates the default MOH/FDA Delay timeline values per location bi-annually according to industry published summaries of expected time for the regulatory authority review of a clinical trial application (CTA) or investigational new drug application (IND) for research involving human subjects for medicinal drug products.
During 2023, the default values for the ClearTrial-supported locations in scope for EU CTR were updated to 125 calendar days from submission to approval, except Norway, which was updated to 106 calendar days from submission to approval. Additional guidance based on the type of product and type of reviews has been added to the context-sensitive help on the Locations tab. You can also click a column header on the Locations tab of a plan/template leveraging the 6.0 Cost Model to see this information.