According to the European Medicines Agency (EMA), from 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS).

Following a one-year transition, CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. With CTIS, sponsors can now apply for authorizations in up to 30 EU/EEA countries at the same time and with the same documentation. The system includes a public, searchable database for healthcare professionals, patients, and other interested parties.

The Clinical Trials Regulation (CTR) foresees a transition period. By 31 January 2025, all ongoing trials that were approved under the Clinical Trials Directive will be governed by the new Regulation and will have to be transitioned to CTIS.

CVBF Regulatory team is willing to assist you, as Sponsor of CTs in the EU, please contact [email protected].

More information is available here.

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By Published On: February 3rd, 2023Categories: News0 Comments