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EudraVigilance and adverse reaction reporting

A little more than two years have elapsed since the new version of EudraVigilance has become effective, and any initial problems, mostly due to the difficulties met by the European authorities in the definition of a transition phase, appear to be solved.

The purpose of the version, that became operational in November 2017, was to streamline and harmonize the reporting management, no more entrusted to national authorities, but rather managed centrally by the European Medicine Agency (EMA), the authority responsible for its development, maintenance and coordination. All this has allowed the improvement of suspected adverse reaction examination, reinforcing the monitoring of medicinal products and making data management more efficient.

As known, EudraVigilance is a European platform for the management and analysis of suspected adverse reactions to medicines that are already authorized or still under clinical trial. Operational as of 2001, it is the reference for the countries of the European Economic Area – not only the EU, but also Iceland, Liechtenstein, Norway and Switzerland.

The data recorded on Eudravigilance

Adverse reaction reports are transmitted electronically to the EudraVigilance database by national authorities, marketing authorization holders or clinical trial sponsors. The data received in this way are collected in two different modules: one for suspected unexpected serious adverse reactions (SUSARs) from sponsors of interventional clinical trials (EVCT, Eudravigilance Clinical Trial); the other for the reports of suspected adverse reactions from health operators, patients, post-authorization studies, scientific literature and so on.

The data regarding authorized products recorded on EudraVigilance are examined periodically, usually once a month or twice a week. The reports included in the platform are used by the PRAC, the EMA Pharmacovigilance Risk Assessment Committee that, depending on the case, can recommend regulatory actions to minimize the risks, inform patients or require post-authorization safety studies.

With the new version, holders can report suspected adverse reactions directly into the EudraVigilance platform, with no mandatory transmission to national authorities, that will receive them in turn via the European database. This is a novelty that implied some pros but also some issues, especially at the beginning.

In fact, if on one hand, the transmission by companies is now more homogenous, with no need to comply with the different methods of transmission provided for by the individual national authorities, on the other the latter had to adapt their national networks to enable the information flow with the European platform.

Locally, it was therefore necessary to make processes and infrastructures of the national systems – designed and set up with older standards and methods – compatible with the new EudraVigilance version. Such harmonization has required time and resources, also including changes during the process.

After the initial delays, however, the system is now fully operational to fulfill its function of monitoring and control of medicinal products safety to protect the health of all European patients.

Written by: Maria Pia Felici

Foto di: stevepb da Pixabay