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EMA (EU)
GUIDANCE FINAL
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
Published: 5/22/2026Detected: 5/22/2026

Summary preview

Clarifies how to prepare PSURs for PSUR single assessment (PSUSA), emphasizing clearer benefit–risk evaluation logic, appropriate clinical/scientific judgement, and consistency with GVP Module VII and ICH E2C (R2).

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safety
clinical
labeling
#PSUR
#PSUSA
#QPPV
#risk-benefit
#ICH E2C (R2)

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