Skip to main content
Log in

Good Pharmacovigilance Practice in Paediatrics: An Overview of the Updated European Medicines Agency Guidelines

  • Commentary
  • Published:
Pediatric Drugs Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.


  1. McMahon AW, Dal Pan G. Assessing drug safety in children—the role of real-world data. N Engl J Med. 2018;378(23):2155–7.

    Article  Google Scholar 

  2. European Union Parliament And Council Of The European. Regulation (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 2006. Accessed 15 April 2019.

  3. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations IV: Paediatric population 2018. Accessed 15 April 2019.

  4. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module V—Risk management systems (Rev 2) 2017. Accessed 15 April 2019.

  5. European Medicines Agency. Guidance on the format of the risk management plan (RMP) in the EU—in integrated format 2018. Accessed 15 April 2019.

  6. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module VIII—Post-authorisation safety studies (Rev 3) 2017. Accessed 15 April 2019.

  7. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module XV—Safety communication (Rev 1) 2017. Accessed 15 April 2019.

  8. Penkov D, Tomasi P, Eichler I, Murphy D, Yao LP, Temeck J. Pediatric Medicine Development: an overview and comparison of regulatory processes in the European Union and United States. Ther Innov Regul Sci. 2017;51(3):360–71.

    PubMed  PubMed Central  Google Scholar 

  9. Blake KV, Zaccaria C, Domergue F, La Mache E, Saint-Raymond A, Hidalgo-Simon A. Comparison between paediatric and adult suspected adverse drug reactions reported to the European medicines agency: implications for pharmacovigilance. Paediatr Drugs. 2014;16(4):309–19.

    Article  Google Scholar 

  10. Trifiro G, Gini R, Barone-Adesi F, Beghi E, Cantarutti A, Capuano A, Carnovale C, Clavenna A, Dellagiovanna M, Ferrajolo C, Franchi M, Ingrasciotta Y, Kirchmayer U, Lapi F, Leone R, Leoni O, Lucenteforte E, Moretti U, Mugelli A, Naldi L, Poluzzi E, Rafaniello C, Rea F, Sultana J, Tettamanti M, Traversa G, Vannacci A, Mantovani L, Corrao G. The role of European healthcare databases for post-marketing drug effectiveness, safety and value evaluation: where does Italy stand? Drug Saf. 2019;42(3):347–63.

    Article  Google Scholar 

  11. Lasky T. In the real-world, kids use medications and devices. Drugs Real World Outcomes. 2017;4:75–8.

    Article  Google Scholar 

  12. Kypridemos C, Allen K, Hickey GL, Guzman-Castillo M, Bandosz P, Buchan I, Capewell S, O’Flaherty M. Cardiovascular screening to reduce the burden from cardiovascular disease: microsimulation study to quantify policy options. BMJ. 2016;353:i2793.

    Article  Google Scholar 

  13. Caro JJ. Discretely Integrated Condition Event (DICE) simulation for pharmacoeconomics. Pharmacoeconomics. 2016;34(7):665–72.

    Article  Google Scholar 

Download references


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.

Author information

Authors and Affiliations


Corresponding author

Correspondence to Carmen Ferrajolo.

Ethics declarations


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.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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).

Download citation

  • Published:

  • Issue Date:

  • DOI: