Guidelines for Pharmacovigilance Expedited Reporting Criteria
1) Purpose
The purpose of this SOP is to establish criteria and procedures for identifying and reporting expedited safety reports of suspected serious adverse reactions (SUSARs) to regulatory authorities within defined timelines.
2) Scope
This SOP applies to personnel responsible for pharmacovigilance case assessment, expedited reporting determination, and submission within the Pharmacovigilance (PV) department.
3) Responsibilities
The Pharmacovigilance (PV) Medical Reviewer is responsible for assessing the seriousness of adverse events and determining the need for expedited reporting. PV Quality Assurance personnel ensure adherence to expedited reporting criteria and timelines.
4) Procedure
4.1 Definition of Expedited Reporting
- Define criteria for expedited reporting based on regulatory guidelines (e.g., ICH E2A, EMA Guideline on Good Pharmacovigilance Practices), including SUSARs that are unexpected and associated with serious outcomes.
- Evaluate adverse events reported in pharmacovigilance against expedited reporting criteria to determine if they meet the criteria for expedited reporting.
4.2 Medical Review
- Conduct medical review of adverse event reports to assess seriousness, causality, and clinical significance.
- Consider relevant medical information, including patient characteristics, concomitant medications, and temporal relationship between medicinal product use and adverse event onset.
4.3 Expedited Reporting Decision
- Determine the need for expedited reporting based on seriousness assessment, causal relationship evaluation, and regulatory reporting criteria.
- Initiate expedited reporting for SUSARs to regulatory authorities and marketing authorization holders (MAHs) within specified timelines (e.g., 7 or 15 calendar days).
4.4 Documentation
- Maintain documentation of expedited reporting decisions, including rationale for reporting determination, supporting clinical evidence, and timeline adherence.
- Record expedited reporting activities in pharmacovigilance case management systems or databases according to standard operating procedures.
4.5 Regulatory Submission
- Compile and submit expedited safety reports to regulatory authorities in accordance with pharmacovigilance regulations and reporting obligations.
- Coordinate with Regulatory Affairs (RA) to ensure timely and accurate submission of expedited reports and responses to regulatory inquiries.
4.6 Quality Assurance Review
- Subject expedited reporting decisions and activities to quality assurance review to verify accuracy, completeness, and compliance with expedited reporting criteria.
- Address feedback and recommendations from PV Quality Assurance personnel to improve expedited reporting practices and documentation.
4.7 Training and Competency
- Provide training to PV Medical Reviewers and PV personnel involved in expedited reporting on regulatory requirements, expedited reporting criteria, and reporting timelines.
- Assess competency of PV staff through periodic evaluations and training assessments to ensure proficiency in expedited reporting procedures.
4.8 Continuous Improvement
- Regularly review and update expedited reporting procedures based on feedback, regulatory changes, and quality assurance findings.
- Implement improvements to expedited reporting processes to enhance efficiency, accuracy, and compliance with pharmacovigilance reporting requirements.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, SUSAR – Suspected Unexpected Serious Adverse Reaction, ICH – International Conference on Harmonization, EMA – European Medicines Agency, MAH – Marketing Authorization Holder
6) Documents, if any
Expedited reporting criteria, expedited reporting forms, training materials.
7) Reference, if any
ICH Guideline for Good Clinical Practice (E6), ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A), EMA Guideline on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products.
8) SOP Version
Version 1.0
