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Drug Saf. 2018 Jul;41(7):665-675. doi: 10.1007/s40264-018-0647-1.

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection.

Author information

1
European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK. rodrigo.postigo@ema.europa.eu.
2
European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.
3
Medicines Evaluation Board, Utrecht, The Netherlands.
4
Agence Fédérale des Médicaments et des Produits de Santé (Member of the Pharmacovigilance Risk Assessment Committee), Brussels, Belgium.

Abstract

The analysis of safety data from spontaneous reporting systems has a proven value for the detection and analysis of the risks of medicines following their placement on the market and use in medical practice. EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy. We performed a literature search including data up to December 2016 to demonstrate how the data from EudraVigilance has been used in scientific publications. We describe the results, including by type of publication, research topics and drugs involved. In 50% of the publications, the data are used to describe safety issues, in 44% to analyse methodologies used in pharmacovigilance activities and in 6% to support clinical perspectives. We also outline a description of the use of the database by the European Union regulatory network. Driven by the full implementation of the 2010 pharmacovigilance legislation, EudraVigilance has undergone further enhancements together with a major revision of its access policy, taking into account the use of the new individual case safety report standard developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. The aim of the broadened access is to facilitate more effective safety monitoring of authorised medicines, to make more data available for research and to provide better access to information on suspected adverse reactions for healthcare professionals and patients. In November 2017, the new full functionalities of EudraVigilance were launched, including the extensive web access to data on suspected adverse drug reactions and the possibilities for academic research institutions to request a more extensive dataset for the purposes of health research. The main objective of this article is to describe the new access to the database together with the opportunities that this new access can bring for research. It is intended to promote an appropriate use of the data to support the safe and effective use of medicines.

PMID:
29520645
PMCID:
PMC5990579
DOI:
10.1007/s40264-018-0647-1
[Indexed for MEDLINE]
Free PMC Article

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