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The authors wish to acknowledge the constructive comments provided by Dionna Green and Ann McMahon from the Food and Drug Administration. The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organisations with which the author(s) is/are employed/affiliated.
No sources of funding were used to prepare this manuscript.
Conflict of interest
Janet Sultana, Cosimo Zaccaria, Roberto de Lisa, Francesco Rossi, Annalisa Capuano and Carmen Ferrajolo have no conflicts of interest to declare.
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Sultana, J., Zaccaria, C., de Lisa, R. et al. Good Pharmacovigilance Practice in Paediatrics: An Overview of the Updated European Medicines Agency Guidelines. Pediatr Drugs 21, 317–321 (2019). https://doi.org/10.1007/s40272-019-00350-w