Abstract

Signal detection by means of EVDAS – within the CoBRA® and EViSiMa® projects

Five years after the launch of the new EudraVigilance system and access to EVDAS, the system has established itself as a routine tool used to assess (validated) signals (including those detected from other sources, e.g. from literature), thus fulfilling its foreseen role as defined by guidelines on signal management in the EU. On the other hand, signal detection based on EVDAS has not become a matter of course in a comparable way. Since the initiation of the signal detection in EVDAS by MAHs on 22. Feb 2018, which was primarily envisaged by the EMA for the detection of signals in EVDAS for selected active substances, the so-called pilot phase has been repeatedly extended, most recently in Aug 2022 until the end of 2023, nonetheless, the legal requirements remain the same as they were almost five years ago. Nevertheless, some processes have been established in the pilot phase to enable meaningful signal detection in EVDAS. The focus of this article is that of a signal management procedure that meets the challenges of the complex data presentation in EVDAS and in the EudraVigilance database by means of an efficient and pragmatic strategy that also takes into account SDRs not prioritised by EMA criteria by means of alternative categorisation; the procedure includes a cumulative monitoring approach that allows continuous monitoring of signals once they have been detected. An integrative view of data retrieved via this process with data from other sources – e.g. literature data and monitoring of authority information – within established procedures of signal management may support the efforts of the regulatory authorities in optimising drug safety.