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European Medicines Agency lists ways to improve data quality for adverse reactions

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Published on: 21 January 2020

Published by LNB News

LNB News 21/01/2020

Document Information

Issue Date: 21 January 2020

Published Date: 21 January 2020

Jurisdiction(s): United Kingdom

Article summary

The European Medicines Agency (EMA) has published its detailed guide regarding the EudraVigilance (EV) data management activities. The guide provides and overview of the data management and quality assurance activities carried out by the EMA, based on information of suspected adverse reactions and medicinal products reported to and held in EV and the extended EV medicinal product dictionary (XEVMPD). The EMA have stated that organisations submitting individual case safety reports (ICSRs) electronically to EV, have to demonstrate that they have an ICH E2B(R2)2 or E2B(R3)3 compliant system.

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