Following the implementation of the new EudraVigilance system, reported in our previous post, and in an attempt to streamline the monitoring of safety signals in EudraVigilance, the European Medicines Agency (EMA) has recently announced that the marketing authorisation holders (MAHs) of 300 specific active substances and combinations of active substances will be required continuously to monitor activities in relation to their substances in EudraVigilance. The scheme will begin on 22 February 2018 and will last one year. During the pilot period, the affected MAHs will be required to inform the EMA and national competent authorities of validated safety signals relating to their medicines. MAHs who are included in the pilot scheme should refer to the guidance contained in the Good Pharmacovigilance Practices (GVP) Module IX – Signal Management in relation to the monitoring and reporting of safety signals. MAHs who are not part of the pilot scheme will not be required to monitor EudraVigilance or to inform the regulatory authorities of validated signals while the scheme is in operation. However, they will have access to EudraVigilance data and will be able to incorporate any relevant new safety data into their own safety monitoring systems. The EMA will use the experience gained during the pilot period to improve the next phase of safety signal detection.

PRAC recommendations

When a safety signal emerges, the Pharmacovigilance Risk Assessment Committee (PRAC) will assess the data and issue recommendations, ranging in severity (e.g., from no action required to urgent safety restrictions). It is advisable for MAHs to keep a close eye on the PRAC recommendations published monthly on the EMA’s website, so that they can take appropriate action without delay.

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