Evaluation of Safety Signal Management in Europe: Insights From PRAC Reports (2016-2024)
Author(s)
Sara Serdarevic, MSc1, Leila Karimi, MD, PhD2, Katia Verhamme, MD, PhD3.
1Université de Bordeaux and Utrecht Universiteit (the EU2P programme), Bordeaux, France, 2Cytel, Rotterdam, Netherlands, 3Erasmus Medical Center University, Rotterdam, Netherlands.
1Université de Bordeaux and Utrecht Universiteit (the EU2P programme), Bordeaux, France, 2Cytel, Rotterdam, Netherlands, 3Erasmus Medical Center University, Rotterdam, Netherlands.
OBJECTIVES: Following the implementation of the revised GVP Module IX in 2018, this study aims to assess the involvement of National Competent Authorities (NCAs) in the signal management activities of the Pharmacovigilance Risk Assessment Committee (PRAC) across European countries between March 2016 and February 2024.
METHODS: A retrospective, descriptive analysis was conducted using 88 PRAC meeting reports published by the European Medicines Agency (EMA). Data on new and follow-up safety signals were manually extracted and categorized by product authorization type (centrally authorized products [CAP], nationally authorized products [NAP], or both), and signal-identifying entity (EMA, NCAs, or others such as Marketing Authorization Holders [MAHs] or unspecified sources). Descriptive statistics were used to summarize trends across four study periods: pre-GVP IX revision (March 2016-February 2018), early post-revision (March 2018-February 2020), COVID-19 pandemic (March 2020-February 2022), and post-pandemic (March 2022-February 2024).
RESULTS: A total of 977 safety signals were analyzed, comprising 528 (54%) newly identified signals and 449 (46%) under follow-up discussion. Regarding stakeholder roles in signal identification, other entities including MAHs contributed the largest share with 332 (62.9%) of new signals, followed by NCAs with 122 (23.1%) and the EMA with 74 (14%). Engagement by NCAs peaked between 2018 and 2020, coinciding with the implementation of the revised GVP Module IX. Over time, the proportion of signals identified by NCAs declined from 36.4% to 16.8%, while EMA contributions increased from 10.1% to 23.4%. Signals related to CAP accounted for the largest proportion (55.2%), followed by NAP (25.7%) and CAP/NAP signals (19.1%). Other entities accounted for the largest proportion of signal identifications in all periods, peaking at 68.9% during the COVID-19 pandemic.
CONCLUSIONS: A shift in signal detection from NCAs to EMA has been observed over time, while contributions from other entities continue to be the highest.
METHODS: A retrospective, descriptive analysis was conducted using 88 PRAC meeting reports published by the European Medicines Agency (EMA). Data on new and follow-up safety signals were manually extracted and categorized by product authorization type (centrally authorized products [CAP], nationally authorized products [NAP], or both), and signal-identifying entity (EMA, NCAs, or others such as Marketing Authorization Holders [MAHs] or unspecified sources). Descriptive statistics were used to summarize trends across four study periods: pre-GVP IX revision (March 2016-February 2018), early post-revision (March 2018-February 2020), COVID-19 pandemic (March 2020-February 2022), and post-pandemic (March 2022-February 2024).
RESULTS: A total of 977 safety signals were analyzed, comprising 528 (54%) newly identified signals and 449 (46%) under follow-up discussion. Regarding stakeholder roles in signal identification, other entities including MAHs contributed the largest share with 332 (62.9%) of new signals, followed by NCAs with 122 (23.1%) and the EMA with 74 (14%). Engagement by NCAs peaked between 2018 and 2020, coinciding with the implementation of the revised GVP Module IX. Over time, the proportion of signals identified by NCAs declined from 36.4% to 16.8%, while EMA contributions increased from 10.1% to 23.4%. Signals related to CAP accounted for the largest proportion (55.2%), followed by NAP (25.7%) and CAP/NAP signals (19.1%). Other entities accounted for the largest proportion of signal identifications in all periods, peaking at 68.9% during the COVID-19 pandemic.
CONCLUSIONS: A shift in signal detection from NCAs to EMA has been observed over time, while contributions from other entities continue to be the highest.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH95
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
No Additional Disease & Conditions/Specialized Treatment Areas