Other Notifications

 

Notifications relating to the progress of the trial, the safety of participants, unexpected events, as well as notifications relating to trial compliance issues, must be submitted exclusively through the European portal CTIS (Clinical Trials Information System), under the provisions of Regulation (EU) No 536/2014.

INFARMED, I.P. and other competent authorities of the European Union (EU) continuously monitor and assess the safety of clinical trials taking place in the European area. The objective is the ongoing evaluation of the benefit-risk balance (deemed favourable at the time of the respective authorisation) so that, where applicable, risk minimisation measures may be implemented, or even the suspension or revocation of the authorisation granted for its conduct.

 

The submission of notifications to INFARMED and CEIC should be done through RNEC if these regards to clinical trials that were submitted through this portal. Otherwise, it should be done independently to these two entities, through the usual pathways.

Since 31 January 2022, safety monitoring and assessment has been carried out in close cooperation and work-sharing among the different Member States, in accordance with the principles set out in the Clinical Trials Regulation, the European Clinical Trials Regulation (EU) No 536/2014, applicable from 31 January 2022, and subsequent rules established in a specific Implementing Regulation, Regulation (EU) 2022/20 of 7 January 2022.

The authorities monitor and assess safety information relating to investigational medicinal products in clinical trials, in particular that submitted by the sponsor (who bears primary responsibility for ensuring the safety of participants).

Examples include data on Suspected Unexpected Serious Adverse Reactions (SUSARs) and Annual Safety Reports, with other various safety information also being submitted and analysed (where necessary and applicable, accompanied from the outset by proposals for risk minimisation measures). All with a view to maintaining a favourable benefit-risk balance and protecting participants.

 

For the submission of notifications, please consult: