Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

By Danélia Botes

February 1, 2023

Introduction:

The Clinical Trials Information System (CTIS) has ushered in a new era for clinical research in the European Union (EU). Since 31 January 2023, all initial clinical trial applications in the EU must be submitted through CTIS, marking a significant shift in the regulatory landscape.

The Dawn of the CTIS:

CTIS has become the singular entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This development followed a one-year transition period, during which sponsors had the option to apply for a new clinical trial under the Clinical Trials Directive or the new Clinical Trials Regulation (CTR), which came into effect on 31 January 2022.

Streamlining Clinical Trial Applications:

Previously, sponsors had to submit clinical trial applications to national competent authorities (NCAs) and ethics committees in each country separately to obtain regulatory approval. With the advent of CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries simultaneously with the same documentation, significantly enhancing efficiency.

Public Access to Clinical Trial Data:

CTIS also includes a public, searchable database for healthcare professionals, patients, and other interested parties. This transparent access to information promotes trust and understanding among all stakeholders involved.

The Future of Clinical Trials:

The application of the CTR is set to enhance Europe’s standing as an attractive location for clinical research. The new regulation simplifies the processes for the application and supervision of clinical trials, as well as their public registration. All clinical trial sponsors will now use the same system and follow the same procedures for the authorisation of a clinical trial, irrespective of their location and the NCA or national ethics committee they are dealing with.

Conclusion:

The Clinical Trials Information System marks a significant step for the standardisation and streamlining of clinical trial processes in the EU. This system paves the way for a more efficient and transparent future. In the evolution of clinical research, the CTIS stands to play a crucial role, fostering a uniform approach. 

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