PV Bulletin
PvBulletin

Category

Regulators

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
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RegulatorsFda

FDA ties TRUE METRIX Safety Communication to Class I recall update

Relevant for
Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadMedical Device Vigilance Lead+3 more
Action needed

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

Process impact
Signal ValidationLocal Affiliate ComplianceDevice Vigilance
SOP impact

7 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →
RegulatorsHealth Canada

Health Canada reposts device recall forms and updates GVP GUI-0102

Relevant for
Local Safety OfficerRegulatory Intelligence LeadMedical Device Vigilance LeadPV Quality Lead+1 more
Action needed

Health Canada update requires triage for Local Affiliate Compliance, Device Vigilance, Inspection Readiness; confirm local obligations and document follow-up actions.

Process impact
Local Affiliate ComplianceDevice VigilanceInspection Readiness
SOP impact

4 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →

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