New EudraVigilance System To Usher In Simplified Reporting of ADRs From Nov. 22
The European Medicines Agency is asking drug companies and EU national competent authorities to prepare for the late November launch of the new EU pharmacovigilance database, which will have enhanced functionalities for reporting and analysing suspected adverse reactions.
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The European Medicines Agency has published details of the drug safety issues it dealt with in 2016, noting that more than 1.2 million adverse drug reaction reports were received and that it reviewed in excess of 2,000 potential safety signals. A total of 118 products were withdrawn from European markets.
The European Medicines Agency has drawn up a list of approximately 3,000 marketing authorization holders that need to be registered to the modernized pharmacovigilance database by November. The agency will tackle the list in alphabetical order, undertaking around 600 registrations per month starting June 1. Companies that fail to apply within the designated monthly slot will be put at the end of the queue, which may delay their access to the database.
Switzerland is on track with plans to adopt a new modernized pharmacovigilance system with enhanced data analysis capabilities. The new system will not result in any changes to how companies and healthcare professionals report adverse drug reactions to Swissmedic.