All initial clinical trial applications across the EU have to be submitted via the Clinical Trials Information System (CTIS) starting January 31, 2023.
As per the European Medicines Agency (EMA), CTIS now happens to be the single-entry point for regulators as well as sponsors of clinical trials when it comes to the submission and assessment of data on it.
All this will follow a transition of one year, during which sponsors will be able to choose whether to apply for a novel clinical trial across the EU/EEA, which is in line with the clinical trials directive, or under the gamut of the Clinical Trials Regulation, which came into existence on January 31 last year.
Traditionally, in order to gain regulatory approval for running a clinical trial, sponsors were asked to submit separate clinical trial applications to the national competent authorities as well as ethics committees in every country. The procedures of registration and result posting were also part of the separate process. With CTIS in place, the sponsors can now apply for approvals in up to 30 EU/EEA nations simultaneously with a common dossier. The system shall include a database that is searchable by patients, healthcare professionals, and other interested parties.
EU and the future clinical trial applications there
The new regulation makes the application and supervision of clinical trials, as well as their public registration, completely seamless. Location as well as which NCA or national ethics committee sponsors are dealing with will not be taken into account.
The CTR looks forward to a three-year transition period from 2022 until 2025. In the coming two years, i.e., by January 2025, all the ongoing trials that are approved under the clinical trials directive shall be governed by the new regulation and have to go through CTIS.
EMA says, all said and done, the CTIR application will go on to strengthen the position of Europe as an attractive destination when it comes to quality clinical research.
Who is responsible for regulating clinical trials across the EU and EEA?
The approval and looking into the work of clinical trials is the responsibility of the member states from the EU and EEA whereas on the other hand, EMA takes the ownership of maintaining the CTIS. The European Commission takes care of clinical trial regulation and execution.