Topic

PV in clinical trials

Pharmacovigilance in clinical trials spans expedited SUSAR reporting, investigator safety communications, and development safety update reports (DSURs). This hub gathers trial-safety regulatory intelligence so PV and clinical safety leads can update SOPs before guidance becomes binding practice.

1 matching update · Sorted by impact priority

publicMedicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) · United Kingdom · Updated Jun 15, 2026

Unique Liaison Programme between MHRA and FDA

Monitoring

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV

verifiedRegulatory action: Notice

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