Emerging Safety Issues in Pharmacovigilance

Delete the record because it is not an ESI Reclassify or manage it through routine signal processes or monitoring, with the decision documented Notify all authorities immediately regardless of reportability Stop all pharmacovigilance activities for the product

Retaining only the final conclusion because preliminary records may create confusion Maintaining controlled, versioned records with timestamps, authors, reviewers, approvals and an audit trail Storing communications only in individual employees' email accounts Allowing retrospective reconstruction without recording contemporaneous decisions

A product-quality deviation with a plausible safety consequence Only a validated disproportionality signal Only a periodic safety update report Only a confirmed adverse drug reaction

A concern requires clinical interpretation, regulatory classification, exposure context and evaluation of possible manufacturing implications A single analyst can resolve every issue without consultation because speed is the only objective Only commercial staff need to be involved because public attention determines ESI status Multidisciplinary review is appropriate only after a product has been recalled

A concise Preliminary Assessment Report with categorisation, risks, data needs and regulatory implications A final periodic benefit-risk report A completed epidemiological study A legally binding product recall decision in every case

Clinical-trial safety reporting and competent-authority timelines must be followed in parallel with the ESI process The issue should be excluded from ESI procedures until marketing authorisation Only post-marketing reporting rules can apply The sponsor may wait for the next periodic report because trial events are internal

A stable, low-severity reporting pattern identified in a periodic analysis A single non-serious event consistent with the established product safety profile A rapidly increasing cluster of unexpected fatal events in a vulnerable population A literature article proposing a theoretical mechanism without clinical outcomes

Speed requires making decisions without recording uncertainty Scientific rigour requires delaying all action until the evidence is conclusive Accelerated review should use structured criteria, expert challenge and proportionate actions while evidence develops Urgent governance makes routine documentation and peer review unnecessary

Remove the timelines from the SOP to avoid non-compliance findings Introduce process metrics, drills and root-cause analysis with corrective actions Limit ESI intake to senior management Replace documented assessment with verbal discussion

Closure without a documented rationale because the initial concern was urgent A documented decision to close as monitored non-ESI, reclassify as a routine signal or proceed to mitigation Automatic deletion of the intake record once no submission is made Closure only when the issue has resulted in a confirmed causal relationship