PV Bulletin
PvBulletin

Tag archive

ICSR

RegulatorsMhraUnited Kingdom

MHRA confirms UK clinical trial safety reporting guidance is effective

Relevant for
Local Safety OfficerRegulatory Intelligence LeadPV Operations LeadPV Quality Lead+2 more
Action needed

Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.

Process impact
Local Affiliate ComplianceICSR SubmissionInspection Readiness
SOP impact

4 SOPs may need review

Urgency: HighConfidence: high
Read impact brief →
DevicesFda

FDA MDR hub highlights VMSR guidance and quarterly malfunction reporting

Relevant for
Local Safety OfficerRegulatory Intelligence LeadPV Operations LeadMedical Device Vigilance Lead+2 more
Action needed

Fda update requires triage for Local Affiliate Compliance, ICSR Submission, Device Vigilance; confirm local obligations and document follow-up actions.

Process impact
Local Affiliate ComplianceICSR SubmissionDevice Vigilance
SOP impact

4 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →
Country GuidesMhra

UK MHRA refreshes PV procedures and adds decentralised manufacture UK GVP

Relevant for
Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadPV Operations Lead+4 more
Action needed

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

Process impact
Signal ValidationRisk ManagementLocal Affiliate Compliance
SOP impact

9 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →

Get updates for your PV role

Subscribe to receive impact-first pharmacovigilance updates tailored by role and workflow.

Current context: role PV Quality Lead, workflow Regulatory Intelligence Monitoring.