EMA Login Portal: Simplifying Clinical Research in Europe

The Clinical Trials Regulation (CTR) has been instrumental in strengthening Europe's position as a preferred location for clinical research. As of today, we have reached an important milestone on our journey towards a harmonized regulatory framework for clinical trials. By January 31, 2025, all ongoing trials approved under the Clinical Trials Directive will be governed by the new Regulation and will need to be transitioned to the Clinical Trials Information System (CTIS).

The CTR provides a three-year transition period from 2022 to 2025, allowing stakeholders to adapt to the new regulatory environment. One of the key benefits of CTIS is its public, searchable database for healthcare professionals, patients, and other interested parties. This database will provide easy access to information on clinical trials taking place across the EU/EEA.

Sponsors can now apply for authorizations in up to 30 EU/EEA countries at the same time and with the same documentation using CTIS. Prior to this, sponsors had to submit separate applications to national competent authorities (NCAs) and ethics committees in each country to gain regulatory approval to run a clinical trial.

To facilitate a smooth transition, there was a one-year period from 2022 to 2023 during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA under the Clinical Trials Directive or under the new CTR. As of January 31, 2023, all initial clinical trial applications in the European Union must be submitted via CTIS.

In summary, CTIS is now the single-entry point for sponsors and regulators to submit and assess clinical trial data. This simplified process will streamline clinical research in Europe, making it easier for stakeholders to collaborate and drive innovation in healthcare.

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