By accessing EMA – CTIS newsflash you have access to regular information provided by the EMA – key updates about the CTIS and links to useful reference materials.

25.07.2025 Clinical Trials Highlights 25 iulie 2025 (ro)

10.06.2025 CTIS newsflash.pdf

27.05.2025 CTIS newsflash.pdf

16.05.2025 CTIS newsflash.pdf

08.04.2025 CTIS newsflash.pdf

25.03.2025 CTIS newsflash.pdf

11.03.2025 CTIS newsflash.pdf
Since February, EMA has offered clinical trial sponsors the opportunity to learn about the functionalities of the CTIS, through brief discussions.
Each of these discussions includes short demonstrations of the functionalities of the CTIS and gives sponsors the opportunity to ask questions.
These discussions are broadcast live on the EMA website, with no registration required for participants.
A recording of each discussion will be available on the respective event page in due course.
The calendar of the series of events held during the first semester of 2022 has been updated, as follows:
– 24 February 14:00-15:30 CET User access and role management (înregistrare disponibilă)
– 23 March 14:00-15:30 CET – Initial clinical trial application (înregistrare disponibilă)

– 28 April 14:00-15:30 CET – Requests for information
– 31 May 16:30-18:00 CET – Modifications
– 23 June 14:00-15:30 CET – Transitional trials and Additional MSC application
Other CTIS-related events shall be added to the EMA events page, throughout 2022.
Interested persons can subscribe to the Clinical Trials newsletter by sending an e-mail to CT.NewsletterSubscriptions@ema.europa.eu.
The clinical trials IT system is now functional!
Through this #EUClinicalTrials system, sponsors can apply for clinical trial authorisations in up to 30 EU countries, with a single application.
The system includes a public database as well: https://euclinicaltrials.eu/home
On 25 January 2022, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published a press release and held a joint press conference to provide an update on the implementation of the Clinical Trials Regulation and the launch of the Clinical Trials Information System (CTIS) on 31 January 2022.
The URL of the Clinical Trials public webpage, which includes the link to the sponsor and authorities’ workspaces, will be available from 31 January, via the EMA website and social media channels.
The press release is available here, and the video recording of the live event is available here.
We also attach the press release in Romanian.
download press release…
Regulation on interventional clinical trials and the CTIS
download document…
The European Medicines Agency (EMA) has published a document providing guidance on the use of the Clinical Trials Information System (CTIS) by sponsors.
This training material has been developed to improve access to the CTIS and includes key considerations regarding user access, roles and responsibilities in the CTIS.
EMA is also conducting a survey in order to collect feedback from sponsors on this document.

We hereby invite you to participate by 17 December 2021: EUSurvey – Survey (europa.eu).
download document…

The event “Clinical Trials Information System (CTIS) – user perspective” took place on 26 October 2021. The aim of this information day was to help future CTIS users prepare for the submission and assessment of clinical trial applications in the system after its launch on 31 January 2022.
The video recording of this event is now available on the EMA website, at the following link: Clinical Trials Information System (CTIS): Virtual information day | European Medicines Agency (europa.eu)