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Borg JJ, Tanti A, Kouvelas D, et al. European Union pharmacovigilance capabilities: potential for the new legislation. Ther Adv Drug Saf. 2015;6(4):120-40doi: 10.1177/2042098615591802.
Borg, J. J., Tanti, A., Kouvelas, D., Lungu, C., Pirozynski, M., Serracino-Inglott, A., & Aislaitner, G. (2015). European Union pharmacovigilance capabilities: potential for the new legislation. Therapeutic advances in drug safety, 6(4), 120-40. https://doi.org/10.1177/2042098615591802
Borg, John Joseph, et al. "European Union pharmacovigilance capabilities: potential for the new legislation." Therapeutic advances in drug safety vol. 6,4 (2015): 120-40. doi: https://doi.org/10.1177/2042098615591802
Borg JJ, Tanti A, Kouvelas D, Lungu C, Pirozynski M, Serracino-Inglott A, Aislaitner G. European Union pharmacovigilance capabilities: potential for the new legislation. Ther Adv Drug Saf. 2015 Aug;6(4):120-40. doi: 10.1177/2042098615591802. PMID: 26301067; PMCID: PMC4530350.
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Ther Adv Drug Saf. 2015 Aug;6(4):120-40. doi: 10.1177/2042098615591802.

European Union pharmacovigilance capabilities: potential for the new legislation.

Therapeutic advances in drug safety

John Joseph Borg, Amy Tanti, Dimitrios Kouvelas, Calin Lungu, Michal Pirozynski, Anthony Serracino-Inglott, George Aislaitner

Affiliations

  1. Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR 1368, Malta.
  2. Medicines Authority, Gzira, Malta.
  3. School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  4. DDCS, Windhof, Luxemburg.
  5. Department of Anaesthesiology and Critical Care Medicine, Postgraduate Medical School, Warsaw, Poland.
  6. Department of Pharmacy, University of Malta, Msida Malta.
  7. National Organisation of Medicines (EOF), Athens, Greece.

PMID: 26301067 PMCID: PMC4530350 DOI: 10.1177/2042098615591802

Abstract

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.

Keywords: Pharmacovigilance and Risk Assessment Committee; adverse drug reactions; drug safety; periodic safety update reports; pharmacovigilance; post authorization safety studies; regulatory affairs; signal detection

References

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  4. Eur J Clin Pharmacol. 2011 Nov;67(11):1199-200 - PubMed
  5. Drug Saf. 2011 Mar 1;34(3):187-97 - PubMed

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