The European pharmacovigilance legislation requires marketing authorization holders (hereinafter MAHs) to continuously monitor the data published in Eudravigilance and to inform the Agency and National Competent Authorities (NCA) of validated signals detected in the database.
On November 22, 2017, it allows to access to the database (EVDAS) includes in EudraVigilance that allows MAH to fulfill its obligations. The guideline for the detection and notification of possible signals is described in Module IX of Good Pharmacovigilance Practices (GVP) for Signal Management.
Last July 2017, in order to simplify this new process, the European Commission (EC) agreed to a gradual implementation of the previous legal requirements:
Initial phase
The initial phase of the application began on February 22nd , 2018, with a duration of one year (until February 22, 2019). For this, a certain number of active substances were chosen according to the list of medicines chosen for additional monitoring.
Extension period of the pilot phase for signal detection.
Last communication informed that EMA considered that more experience is needed during the pilot phase. Therefore, it has been agreed to extend the pilot phase with the European Commission. This means that after this date, only MAHs with an active substance or a combination of them included in the pilot phase list should continue to perform signal detection for these substances in EudraVigilance.
In the future…
In September 2019, the European Agency will finalize a report that will include the results of the first year of experience (February 2018 – February 2019), including aspects of workload and process.
The EMA intends to conduct a brief survey of the MAHs involved in the pilot project about their experience, including the signals reported in PSUR or the safety variations in line with the process described in GVP Module IX. Therefore, it is suggested that the MAHs register this information prospectively.
At the end of December 2019, based on the conclusions of the previous report, a decision will be made on:
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How will the next phase of implementation be?
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What products will be included?
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What will be the effective date?
The EMA will communicate all this information to interested parties.
Moreover, the European Medicines Agency continues to support MAHs through e-learning modules and webinars.
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