CTIS set to launch in EU; sponsor guide now online

Regulatory NewsRegulatory News | 02 August 2021 |  By 

The European Commission (EC) has affirmed that it plans to launch the Clinical Trials Information System by the end of January 2022, as part of its broader efforts to modernize and streamline the conduct and oversight of clinical trials in the EU.
“The pandemic has clearly shown the importance of efficient clinical trials that do not compromise on rigorous safety and efficacy standards,” said Stella Kyriakides, EC commissioner for health and food safety, speaking of the 31 July decision.
The Clinical Trials Information System (CTIS) is an information technology tool whose use will be mandatory for new clinical trials under the Clinical Trials Regulation after 31 January 2022. During a one-year grace period following the launch of the Regulation, however, new applicants may choose whether they wish to file an application for a clinical trial under the existing Clinical Trials Directive or the Regulation.
Clinical trials that were launched before implementation of the Clinical Trials Directive may still continue under that system through end of January 2025. At that point, “all ongoing trials approved under the current clinical trial directive will need to transition to the new Regulation,” wrote the EC in announcing the adoption of CTIS.
The EMA has a website that offers training and support for the transition to CTIS; a sponsor handbook was made newly available on 29 July. Required structured data form templates are now also available at the CTIS website.
CTIS is part of an information toolkit that EMA will use to achieve a more coordinated approach to clinical trial safety reporting; implementation of the Clinical Trials Regulation will eventually result in “substantial changes” in how clinical trials are authorized, and how human research is conducted and supervised within the EU.
The Regulation, broadly, is meant to harmonize and increase efficiency for clinical trials, with a single application portal and database for all trials conducted in the EU. Similarly, all trials will be authorized via a single procedure. Increased transparency and access to clinical trials data is also planned under the new Regulation, according to an EC website that details the plans for full application of the Clinical Trials Regulation.
“With the Clinical Trials Regulation, we will be able to guarantee higher safety protection for participants of clinical trials, support EU-wide clinical trials, and deliver faster access to the most promising safe and effective medical products to citizens, for the COVID-19 crisis and beyond,” said Kyriakides.
CTIS website


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Tags: clinical, CTIS, EC, EMA, EU, trials

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