Clinical Trials Information System (CTIS) – German Implementation (BfArM)

Overview of CTIS

The Clinical Trials Information System (CTIS) is the central EU platform established under Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Since its full implementation on 31 January 2022, CTIS replaced the previous EudraCT system and national portals for all new clinical trial applications in the EU/EEA. It enables sponsors to submit a single application dossier for multinational trials, which is then assessed jointly by all concerned Member States. CTIS - Clinical Trials Information System - BfArM

Key Features and Processes

• Single Application Portal: Sponsors submit one harmonised application via CTIS, covering all participating countries.
• Joint Assessment: A Reporting Member State (RMS) coordinates the scientific and ethical assessment; other Concerned Member States (CMS) provide input within strict timelines.
• Public Register: CTIS contains a publicly accessible register with trial information, subject to transparency rules (some data deferred for commercial protection).
• Lifecycle Management: Amendments, substantial modifications, end-of-trial reports, and safety reporting are handled within CTIS.

BfArM’s Role in Germany

BfArM is the competent authority for clinical trials of investigational medicinal products (IMPs) in Germany (excluding certain vaccines/biologics handled by PEI). Responsibilities include:

• Acting as RMS or CMS in multinational trials.
• Conducting national scientific and ethical assessments (in cooperation with ethics committees).
• Granting or refusing authorisations for trials conducted in Germany.
• Supervising ongoing trials, including inspection and vigilance activities.
• Processing applications for mono-national trials.

Application and Assessment Timelines

• Initial application: 60 days for assessment (extendable).
• Substantial modifications: 38 days (or faster for urgent safety issues).
• Ethics committees provide opinions concurrently with BfArM’s scientific assessment.
• Authorisation is granted if no grounds for refusal exist after coordinated review.

Transparency and Public Access

CTIS promotes transparency by publishing trial protocols, summaries of results, and lay summaries. Deferrals and redactions are possible for commercially sensitive information. German-specific requirements (e.g., insurance, investigator qualifications) are addressed during national assessment.

Practical Guidance

BfArM provides detailed information on CTIS usage, German-specific requirements, fees, and contacts. Sponsors are encouraged to use the EU CTIS portal and consult BfArM early for complex or Germany-specific aspects.

CTIS harmonises clinical trial conduct across the EU while allowing Member States like Germany to maintain national oversight through authorities such as BfArM. CTIS - Clinical Trials Information System - BfArM