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Volume: 4 Issue: 8
(August 2017)

continued legislative policy development eudravigilance database eudravigilance huge database containing over 10 million separate data entries first launched 2001

Europe EU US UK

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The continued legislative and policy development of the EudraVigilance database

EudraVigilance is a huge database containing over 10 million separate data entries. It was first launched in 2001 to manage and analyse information in the form of individual case safety reports (‘ICSRs’) on suspected adverse reactions to medicines. The system is hosted by the European Medicines Agency (‘EMA’) which operates the system on behalf of the medicines regulatory network of the Member States of the EU and EEA. EudraVigilance has evolved over the years in order to respond to the ever changing environment in which medicines are being developed, prescribed, used, monitored and regulated, including most recently in the shape of a new version of the system that is due to go live on 22 November 2017. Dr Lincoln Tsang, Partner at Arnold & Porter Kaye Scholer LLP, here explores the purpose and development of the EudraVigilance system, looks at the new, updated system, and considers the impact of Brexit on the UK’s involvement in drug safety regulation and access to the EudraVigilance system going forward.

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