Reminder: Safety Reporting in EU During the Transitional Period from CTD to CTR

As the transitional period from the Clinical Trials Directive (CTD) to the Clinical Trial Regulation (EU No 536/2014, CTR) draws to a close, it’s crucial to review the safety reporting requirements under both systems. With only months remaining before the transition completes, here’s a detailed overview of the essentials.

Safety Reporting Rules During and Beyond the Transitional Period

During this transitional period, safety reporting to national competent authorities (NCAs) and ethics committees (ECs) depends on whether the trial falls under the CTD or CTR.

Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting

• Consistent Rules: Regardless of whether the trial is governed by the CTD or CTR, SUSARs must be submitted via Eudravigilance, ensuring a unified submission process and standardized procedures.

Development Safety Update Report (DSUR) Reporting

• CTD Trials: DSURs must be reported directly to the Member State where the trial is authorized.
• CTR Trials: DSURs are submitted centrally to the Clinical Trials Information System (CTIS).
• Combination of CTD and CTR Trials: If at least one trial is under CTR, submitting DSURs to CTIS is sufficient. A cover letter listing all Member States where trials are authorized, including those under the Directive, should be included.

Ethics Committees (ECs) Reporting

• CTD Trials: Follow the existing rules according to CT-3 and any national legislation.
• CTR Trials: EC reporting is generally not required, except for certain exceptions like Luxembourg. Member States will determine at the national level if ECs need to be involved and how they will access relevant information.

Combination of CTD and CTR Trials: EC reporting is necessary only for Member States where trials fall under the Directive.

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Note: While reporting is harmonized across Member States, some national exceptions or additions may apply. Always check local safety reporting requirements for the applicable countries.

Understanding Clinical Trial Regulation (EU No 536/2014, CTR)

Historical Context

Before 2004, clinical trials in the EU were regulated individually by Member States. The introduction of Directive 2001/20/EC aimed to harmonize procedures but led to fragmentation due to varying interpretations. The EU proposed the Clinical Trials Regulation to streamline and harmonize the process across all Member States.

Key Features of CTR

• Centralization: Unlike directives, the regulation does not require national implementation, ensuring uniform application.
• CTIS: The Clinical Trials Information System serves as a central platform for clinical trial submissions, eliminating parallel processes and improving communication.

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Transitional Period

Starting from January 31, 2022, a three-year transitional period was provided to transfer trials from the Directive to the Regulation. By January 31, 2025, all eligible clinical trials must be conducted under CTR.

Key Milestones

• January 31, 2022: CTR introduced.
• January 31, 2023: All new trials must be registered under CTR.
• January 31, 2025: All active trials in the EU must be registered under CTR.

Useful Tips

• CTIS Access: Organizations need to be registered through the Organizations Management Service (OMS).
• IMP Registration: The investigational medicinal product (IMP) must be added to the extended Eudravigilance medicinal product dictionary (XEVMPD) before a clinical trial application (CTA).
• Trial Numbers: Trials under CTR receive an EU number assigned in the CTIS instead of an EudraCT number.

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For more detailed information, refer to EudraLex – Volume 10 and the European Medicines Agency’s website.

Need Help with Safety Reporting? Contact PrimeVigilance

Navigating the complexities of safety reporting during this transitional period can be challenging. PrimeVigilance offers expert guidance and support to ensure compliance with both CTD and CTR requirements.

Contact us today to learn how we can assist you in managing your safety reporting obligations effectively. Ensure your clinical trials are compliant and your safety reporting is seamless with PrimeVigilance.