Periodic Benefit-Risk Evaluation Report: A European Union Regulatory Perspective


New European Union (EU) pharmacovigilance legislation, effective from July 2012, introduced new concepts and procedures to optimise the way medicines are regulated within the Union and provided new channels for public health interventions. Triggered by the EU legislation, the work done by the International Conference on Harmonisation (ICH) has provided a… (More)
DOI: 10.1007/s40290-014-0071-5


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