Modernized Pharmacovigilance Database Nears In Switzerland
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.
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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.
The UK’s current oversight of pharmacovigilance systems is dependent on its access to several databases and centralized systems designed to serve the single EU market. If the UK cannot have continued access to these systems post Brexit, companies may face duplicative requirements and greater workload.
The European Medicines Agency is examining the “constructive and pragmatic” feedback it has received on its revised guideline on safety signal detection, which aims to help companies fulfil their new legal obligation to monitor EudraVigilance data and report validated signals within strict timelines.