The Pharmaceutical Services of the Ministry of Health, following an announcement of the European Medicines Agency (EMA), inform all stakeholders that, from 31 January 2023, the use of the Clinical Trials Information System (CTIS) for the submission of new applications for the conduct of clinical trials will become mandatory.
CTIS will be the single point of entry for sponsor submission and regulatory review of all new clinical trial applications.
The mandatory use of CTIS for new applications follows the end of the first year of the three-year transitional period during which sponsors could choose whether to submit a new clinical trial application under the Clinical Trials Directive 2001/20/EC or under the new Clinical Trials Regulation (CTR) which entered into force on 31 January 2022.
During the next two-year phase of the transitional period, sponsors will be able to continue to submit applications for substantial amendments to ongoing clinical trials under Directive 2001/20/EC. From 31 January 2025 onwards, all clinical trials will be governed by the CTR. Therefore, clinical trials conducted under Directive 2001/20/EC will have to transition to the new Regulation and be fully transferred to the CTIS before 31 January 2025.
In the context of the national implementation of the procedures provided for by the CTR, the Pharmaceutical Services inform that, from 31 January 2023, new applications for conducting clinical trials in Cyprus submitted outside the CTIS will not be accepted.
Interested parties are encouraged to refer to the European website for further information and information, as well as training on the CTIS: https:/euclinicaltrials.eu
(AF)
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