The State Agency of Medicines reminds that clinical trials registered under the Clinical Trials Directive (CTD) and which are likely to continue beyond January 30, 2025, must transfer to the Clinical Trials Regulation (CTR). Detailed requirements for the transition of clinical trials are provided by the European Commission In Guidelines for Transition to Clinical Trials.
Sponsors can transition clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation (CTR) until the end of the 3-year transition period on January 30, 2025, without interrupting or suspending the relevant clinical trial.
However, sponsors should take into account the time required to complete the research registration procedure in accordance with Chapter 2 of the CTR and the European Commission instructions. Therefore, sponsors should seriously consider submitting applications by January 30, 2025, considering the time required for evaluation, which can take from 1 week (in the case of an expedited process) up to 106 daysif a complete research application is submitted.
By the end of October 2023, only about 390 transition studies have been submitted to the Clinical Trials Information System (CTIS) out of about 4,000-6,000 clinical studies that must complete the transition process by January 30, 2025.
In Latvia, as of November 1 of this year, 19 transitional research applications have been submitted out of 140 ongoing research in accordance with the CTD.
To support sponsors transitioning their clinical trials to CTR/CTIS, on the CTIS website (under ‘Research Transition’) additional resources and guidance from the European Medicines Regulatory Network are available.
In Latvia, there is no fee for the transition of clinical studies from CTD to CTR.
Source: ZVA
2023-11-02 14:50:59
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