The landscape of pharmacovigilance in the European Union is set to evolve with upcoming changes to Implementing Regulation (EU) No 520/2012. This regulation initially mandated Marketing Authorisation Holders (MAHs) to actively monitor the EudraVigilance (EV) database for potential safety signals and promptly inform the European Medicines Agency (EMA) and National Competent Authorities (NCAs) of any validated signals detected. To assess the practical implementation of these requirements, a pilot program was launched in 2018.
Initiated on February 22, 2018, this pilot focused on a select group of active substances and their combinations, as detailed in the ‘pilot list of active substances‘. During this trial phase, only MAHs dealing with substances on this specific list were obligated to conduct signal detection within EudraVigilance and adhere to the reporting protocols.
Based on the insights and experiences gathered throughout this pilot phase, Implementing Regulation (EU) No 520/2012 is now undergoing revisions. These amendments are designed to refine the obligations for MAHs in the realm of signal detection and pharmacovigilance.
The updated regulation is anticipated to be published within the first half of 2025. Consequently, the EudraVigilance signal detection pilot program for MAHs, in its current form, will be extended beyond the close of 2024. It will officially conclude upon the enforcement of the revised Implementing Regulation (EU).
The stipulations outlined in the forthcoming updated regulation will broaden in scope, applying to all MAHs holding marketing authorisations for medicinal products within the European Economic Area (EEA). This signifies a wider implementation of the signal detection responsibilities across the pharmaceutical industry in Europe.
To align with these regulatory updates, GVP Module IX on ‘Signal Management‘ will be amended accordingly. This ensures that the guidance framework keeps pace with the evolving regulatory requirements. The EMA remains committed to supporting MAHs in their signal management endeavors and provides resources such as ‘EudraVigilance training and support‘ for further assistance.
Guidance concerning the notification of ‘emerging safety issues‘ is readily available through EMA’s contact resources. Furthermore, EMA has disseminated ‘scientific guidance‘ on screening methodologies for adverse reactions within EudraVigilance. This guidance is intended for use by the Agency, NCAs, and MAHs, detailing recommended methods implemented within EudraVigilance for adverse reaction screening.
