Getting ready for full implementation of the EU Clinical Trial Regulation
The countdown is on for the European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) with a go-live date of 31 January 2022. The implementation of the CTR will bring about significant changes to the way clinical trials are conducted in the EU. In this article Cromos Pharma considers some of the requirements for sponsors.
The EU CTR will replace the European Clinical Trials Directive (2001/20/EC) and is intended to harmonize the registration, assessment and supervision of clinical trials across all member states via the CTIS. The CTIS, set up and maintained by the EMA, will host the EU Portal and Database for all EU clinical trials.
EU CTR requirements for sponsors of clinical trials
While the CTR is designed to simplify and harmonize clinical trial regulation in the EU, it will also demand new requirements from sponsors. These include:
- Sponsors and CROs will need to be ready to manage Clinical Trial Application processes in the CTIS.
- The CTR mandates a maximum of 12 days for sponsors and CROs to respond to Requests for Information.
- Clinical trial supplies must comply with new IMP labelling requirements.
- SOPs must be compliant with EU CTR by the go-live date.
- Sponsors must comply with new public disclosure requirements for their clinical trials.
Cromos Pharma and the EU CTR
Cromos Pharma has in-depth regulatory expertise and experience in supporting pharma and biotech sponsors to navigate regulatory complexities. Our team is ready to help in smoothing the transition to the EU CTR by advising on protocol language and necessary new processes and ensuring compliance with new requirements.