The system is used to manage and analyse information on suspected adverse reactions to medicines that need to be reported in the European Union (EU). It is operated by the EMA on behalf of the EU medicines regulatory network. The system itself supports the safe and effective use of medicines by facilitating the electronic exchange of individual case safety reports between the EMA, national competent authorities, marketing authorisation holders (MAHs) and the World Health Organisation (WHO). It also facilitates the early detection and evaluation of possible safety signals and enables better product information for medicines authorised in the European Economic Area (EEA).
This long-anticipated update follows on from the independent audit of the system completed earlier in 2017. The recommendations provided by the Pharmacovigilance Risk Assessment Committee (PRAC) were favourable, confirming that the EMA is on track. These revisions will ensure that the database achieves full functionality and the system meets the operational specifications.1
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