The European Clinical Trials Regulation (CTR), which harmonises the procedures for the submission, evaluation and supervision of clinical trials conducted in the European Union (EU), comes into force on 31 January, the European Medicines Agency announced.
As noted, the basis of the changes is the new Clinical Trials Information System (CTIS), which will be the single entry point for sponsors and clinical trial regulators to submit and evaluate clinical trial data and which will include a searchable public database for healthcare professionals, patients and the general public.
Until now, sponsors have had to submit separate applications to national competent authorities and ethics committees in each country to obtain regulatory approval to conduct a clinical trial, while registration and publication of results were separate processes.
Through the CTIS, sponsors will now be able to apply for authorisations in up to 30 countries in the European Union and the European Economic Area at the same time and with the same documentation. Publication of trial data is built into the system.
The implementation of the CTR and the launch of CTIS in the EU and EEA aims to streamline the submission and oversight of clinical trials and their public registration: all clinical trial sponsors will use the same system (CTIS) and follow the same process to apply for authorisation of a clinical trial, regardless of where they are located and which national competent authority or ethics committee they deal with.
The new system has a dedicated secure workspace for sponsors to submit and manage clinical trial applications. There is a similar secure workspace for authorising authorities, who can easily contact the sponsor and quickly collaborate and exchange information with other authorities.
The CTIS still includes a publicly accessible searchable website, which will contain detailed information and results of all clinical trials authorised through the system.
The Clinical Trials Regulation provides for a three-year transitional period. Member States will work on the CTIS immediately after the system goes live, but until 31 January 2023, applicants will still be able to choose whether to submit their application to start a clinical trial under the current system (Directive 2001/20/EC) or through the CTIS.
From 31 January 2023 onwards, submission of applications becomes mandatory via CTIS and by 31 January 2025, all ongoing trials authorised under Directive 2001/20/EC for clinical trials will have to switch to the new Regulation and CTIS.
The authorisation and supervision of clinical trials is the responsibility of the EU/EEA Member States while the European Medicines Agency (EMA) is responsible for maintaining the CTIS, the Communication notes. The European Commission oversees the implementation of the CTR.
Source: Cyprus Times
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