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.
A quick note to inform you that the EMA launched its new improved version of the Eudravigilance system on 22 November 2017. It is now mandatory to report suspected ADRs through the new system.
The new system has been designed to offer “enhanced features for the reporting and analysis of suspected adverse reactions, to support stronger safety monitoring of medicines and a more efficient reporting process for stakeholders”. It will be interesting to monitor whether the system delivers these improvements, as time passes, and users become more familiar with it.
In advance of the launch of the new EudraVigilance System, on 22 November 2017, the EMA has published (on 5 July 2017) a 29 page Q&A, which is a summary of the broad ranging pre-launch questions submitted by stakeholders and the EMA’s answers. Answers have been kept succinct, with URL links to any further relevant guidance. The document is split into separate topics, including: Eudravigilance organisation and user registration; Reporting to National Competent Authorities in the EEA; and Technical Questions, with an index and a useful glossary of terms at the beginning of the guide. The Q&A will be updated regularly. The EMA recommends that the Q&A be treated as a first reference point for queries, before users contact the Agency’s service desk.