{"id":11803,"date":"2026-03-06T11:30:08","date_gmt":"2026-03-06T08:30:08","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=11803"},"modified":"2026-03-06T14:20:33","modified_gmt":"2026-03-06T11:20:33","slug":"ctis","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/studii-clinice\/ctis\/","title":{"rendered":"CTIS"},"content":{"rendered":"\n\n\n\n\n\n\n\n\n\n
\nBy accessing EMA \u2013 CTIS newsflash<\/a><\/strong> you have access to regular information provided by the EMA \u2013 key updates about the CTIS and links to useful reference materials.
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\n25.07.2025<\/strong> Clinical Trials Highlights 25 iulie 2025 (ro)<\/a>
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\n10.06.2025<\/strong> CTIS newsflash.pdf<\/a>
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\n27.05.2025<\/strong> CTIS newsflash.pdf<\/a>
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\n16.05.2025<\/strong> CTIS newsflash.pdf<\/a>
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\n08.04.2025<\/strong> CTIS newsflash.pdf<\/a>
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\n25.03.2025<\/strong> CTIS newsflash.pdf<\/a>
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\n11.03.2025<\/strong> CTIS newsflash.pdf<\/a>\n<\/td>\n<\/tr>\n
Since February, EMA has offered clinical trial sponsors the opportunity to learn about the functionalities of the CTIS, through brief discussions.
\nEach of these discussions includes short demonstrations of the functionalities of the CTIS and gives sponsors the opportunity to ask questions.
\nThese discussions are broadcast live on the EMA website, with no registration required for participants.
\nA recording of each discussion will be available on the respective event page in due course.
\nThe calendar of the series of events held during the first semester of 2022 has been updated, as follows:
\n– 24 February 14:00-15:30 CET User access and role management<\/a> (\u00eenregistrare disponibil\u0103)<\/em>
\n– 23 March 14:00-15:30 CET – Initial clinical trial application<\/a> (\u00eenregistrare disponibil\u0103)<\/em><\/li>\n

– 28 April 14:00-15:30 CET \u2013 Requests for information<\/a>
\n– 31 May 16:30-18:00 CET \u2013 Modifications<\/a>
\n– 23 June 14:00-15:30 CET \u2013 Transitional trials and Additional MSC application<\/a>
\nOther CTIS-related events shall be added to the EMA events page<\/a>, throughout 2022.
\nInterested persons can subscribe to the Clinical Trials newsletter by sending an e-mail to CT.NewsletterSubscriptions@ema.europa.eu<\/a>.<\/td>\n<\/tr>\n

The clinical trials IT system is now functional!<\/strong>
\nThrough this #EUClinicalTrials system, sponsors can apply for clinical trial authorisations in up to 30 EU countries, with a single application.
\nThe system includes a public database as well: https:\/\/euclinicaltrials.eu\/home<\/a>
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.
\nThe URL of the Clinical Trials public webpage, which includes the link to the sponsor and authorities\u2019 workspaces, will be available from 31 January, via the EMA website and social media channels.<\/td>\n<\/tr>\n
\nThe press release is available here<\/a>, and the video recording of the live event is available here<\/a>.
\nWe also attach the press release in Romanian.
\ndownload press release… <\/a> <\/td>\n<\/tr>\n
Regulation on interventional clinical trials and the CTIS<\/strong>
\ndownload document…<\/a> <\/td>\n<\/tr>\n
The European Medicines Agency (EMA) has published a document providing guidance on the use of the Clinical Trials Information System (CTIS) by sponsors.
\nThis training material has been developed to improve access to the CTIS and includes key considerations regarding user access, roles and responsibilities in the CTIS.
\nEMA is also conducting a survey in order to collect feedback from sponsors on this document.<\/p>\n

We hereby invite you to participate by 17 December 2021: EUSurvey – Survey (europa.eu)<\/a>.
\ndownload document…<\/a> <\/td>\n<\/tr>\n

The event \u201cClinical Trials Information System (CTIS) \u2013 user perspective\u201d 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.
\nThe 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)<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

By accessing EMA \u2013 CTIS newsflash you have access to regular information provided by the EMA \u2013 key updates about […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1078,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-11803","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/11803","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=11803"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/11803\/revisions"}],"predecessor-version":[{"id":11831,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/11803\/revisions\/11831"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1078"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=11803"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}