
EMA Issues Guidance on Periodic Safety Update Reports
The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.
On April 6, 2017, the European Medicines Agency (EMA) released two guidance documents to help improve the process of assessing periodic safety update reports (PSURs). Marketing authorization holders submit PSURs, which evaluate the benefits and risks of a medication, to the agency after authorization. EMA uses the reports to assess the benefit-to-risk balance of the medication to determine the continued safety of the drug. Products that contain the same API or combination of APIs are assessed jointly in a single assessment procedure.
The assessment process was streamlined to “ensure that all the evidence generated about medicines containing the same active substance is reviewed at the same time by one authority, resulting in consistent safety information,” EMA stated in a
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