Abstract
April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of its commitment to continuous process improvement. Two new documents aim at improving the safety information and benefit-risk assessment of medicines in the context of the periodic safety update single assessment (PSUSA): Explanatory note to GVP Module VII and Assessors’ questions and answers (Q&A) guidance on PSUR single assessment (PSUSA).
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