Streamline your EU Clinical Trial Regulation (CTR) submissions with our tailored approach. X Pharma Plus ensures full compliance—from Clinical Trial Application (CTA) management to data transparency and CTIS submissions. Focus on innovation while we expertly handle all your EU CTR requirements.
Clinical Trials Regulation (CTR) – Overview
The EU Clinical Trials Regulation (CTR) has replaced the previous Clinical Trials Directive and national implementing legislation, establishing a unified framework for clinical trials in EU Member States. Under this regulation, all new clinical trial applications (CTAs) must be submitted via the Clinical Trials Information System (CTIS), which is used by both national EU Member States and EU/EEA regulators.
Key points for EU CTR adoption and readiness:
- Transition of ongoing trials: All ongoing clinical trials in the EU must be migrated to CTIS.
- Transparency rules: The CTIS transparency rules are applicable for all submissions. Detailed guidance is available on the EMA webpage (euclinicaltrials.eu).
- Submission planning: Sponsors should account for the Member State review procedure, which may take several months. Early submission is recommended to avoid delays.
These requirements highlight the importance of having a Regulatory partner who can efficiently manage submissions, ensure compliance, and meet critical timelines.
Clinical Trials Regulation (CTR) – Services
“Regulation governing the authorization, conduct, and supervision of clinical trials to ensure patient safety and data reliability.”