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Article History

Accepted: 29 May 2024

First Online: 10 July 2024

Declarations

:

: No specific funding was received for the conduct of this study.

: Priya Bahri, Georgy Genov, Peter Arlett, Viola Macolić Šarinić, Evdokia Korakianiti, Alexis Nolte, Martin Huber, and Sabine M.J.M. Straus have no conflicts of interests to declare.

: This article did not require ethics approval as no research in humans or animals was conducted for the purpose of this article.

: This article did not require consent to participate as no research in humans was conducted for the purpose of this article.

: This article did not require consent to publication as no research in humans was conducted for the purpose of this article.

: Data sharing is not applicable to this article, as no datasets were generated or analysed for the purpose of this article.

: Not applicable to this article.

: This article was developed in three steps. The first step was an in-depth discussion between PB, GG, PA, EK and SS on their observations and insights. Based on this discussion, a discussion with AN, and data from the regular EU system assessments, the SCOPE Joint Action, and studies, PB prepared the analysis in Table , developed the guiding principles and provided a first draft of the manuscript for comments by GG, PA, EK, AN and SS. As a second step, the revised draft was critically reviewed and expanded by VMS and MH. As a third step, all authors independently provided their views on the priority elements for consolidating the vision of future pharmacovigilance. All authors reviewed the mature draft, which was finalised by PB, GG and PA for journal submission. The revised manuscript addressing the journal’s reviewers’ comments was reviewed by all authors. All authors read and approved the final version of this manuscript.