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Clinical Trials Information Systems Made Mandatory in EU
The European Medicines Agency (EMA) has announced that any clinical trial applications submitted in the EU must be made via the Clinical Trials Information System. This makes the Clinical Trials Information System the single-entry point for submission and assessment of clinical trial data for both sponsors and regulators.
Official implementation of the new Regulation follows a one-year transition, whereby EU sponsors could decide whether to apply for a new clinical trial in line with either the Clinical Trials Director or the Clinical Trials Regulation, which came into effect back in January 2022.
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Previously, clinical trial applications were submitted separately to national competent authorities and ethics committees within each country. A separate process then had to be completed for the official registration and result posting.
Now, the Clinical Trials Information Systems allows for simultaneous application in up to 30 EU countries with the same document. The EMA describes the implementation as “support[ing] the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission.”
The system is made up of a searchable public website and database for healthcare professionals, patients, and other invested parties. According to the Clinical Trial Regulations committee, there will be a three-year transition period for the mandate’s complete implementation.
They project that by 31st January 2025, all ongoing trials that the Clinical Trials Directive had previously approved will have to be transitioned to the Clinical Trials Information Systems and governed by the new Regulation. “The application of the [Clinical Trial Regulation] strengthens Europe as an attractive location for clinical research,” the EMA’s official announcement reads.
According to the Clinical Trial Regulations committee, there will be a three-year transition period for the mandate’s complete implementation
“The new Regulation streamlines the processes for the application and supervision of clinical trials, and their public registration: all clinical trial sponsors will now use the same system and follow the same procedures to apply for the authorisation of a clinical trial, no matter where they are located and which National Competent Authority (NCA) or national ethics committee they are dealing with.”
Whilst the EMA is responsible for maintaining the Clinical Trials Information Systems, member states of the EU and EEA must be accountable for the authorisation and oversight of clinical trials. The European Commission manages the application of Clinical Trials Regulation.
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