Guidelines for Pharmacovigilance Aggregate Report Distribution
1) Purpose
The purpose of this SOP is to define procedures for the distribution of pharmacovigilance aggregate reports to regulatory authorities, marketing authorization holders (MAHs), and other stakeholders in compliance with regulatory requirements.
2) Scope
This SOP applies to personnel responsible for pharmacovigilance aggregate report generation, review, and distribution within the Pharmacovigilance (PV) department.
3) Responsibilities
The Pharmacovigilance (PV) Manager is responsible for overseeing the distribution of pharmacovigilance aggregate reports. PV Quality Assurance personnel ensure adherence to distribution procedures and regulatory requirements.
4) Procedure
4.1 Report Compilation
- Compile pharmacovigilance aggregate reports (e.g., Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs)) according to predefined schedules and regulatory requirements.
- Ensure completeness, accuracy, and consistency of data and information included in aggregate reports through thorough review and validation processes.
4.2 Distribution List
- Develop and maintain a distribution list specifying regulatory authorities, MAHs, internal stakeholders, and other recipients requiring pharmacovigilance aggregate reports.
- Regularly update the distribution list based on regulatory changes, stakeholder requirements, and organizational updates.
4.3 Distribution Process
- Initiate distribution of pharmacovigilance aggregate reports to stakeholders in accordance with predefined distribution timelines (e.g., quarterly, annually).
- Utilize secure communication channels or designated platforms for transmitting aggregate reports to ensure confidentiality and
4.4 Regulatory Submission
- Submit pharmacovigilance aggregate reports to regulatory authorities within specified deadlines and in compliance with regulatory requirements (e.g., EMA, FDA).
- Coordinate with Regulatory Affairs (RA) to facilitate timely and accurate submission of aggregate reports and responses to regulatory queries.
4.5 Quality Assurance Review
- Subject pharmacovigilance aggregate report distribution activities to quality assurance review to verify accuracy, completeness, and compliance with distribution procedures.
- Address feedback and recommendations from PV Quality Assurance personnel to enhance distribution processes and ensure regulatory compliance.
4.6 Training and Competency
- Provide training to PV personnel involved in aggregate report compilation and distribution on regulatory requirements, report formats, and distribution protocols.
- Assess competency of PV staff through periodic evaluations and training assessments to ensure proficiency in aggregate report distribution.
4.7 Continuous Improvement
- Regularly review and update aggregate report distribution procedures based on feedback, regulatory changes, and quality assurance findings.
- Implement improvements to distribution processes to enhance efficiency, accuracy, and stakeholder satisfaction in pharmacovigilance reporting.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, MAH – Marketing Authorization Holder, PSUR – Periodic Safety Update Report, PBRER – Periodic Benefit-Risk Evaluation Report, PADER – Periodic Adverse Drug Experience Report, EMA – European Medicines Agency, FDA – Food and Drug Administration, RA – Regulatory Affairs
6) Documents, if any
Distribution list, distribution schedules, training materials.
7) Reference, if any
EMA Guideline on Good Pharmacovigilance Practices (GVP) Module VII – Periodic Safety Update Reports, FDA Guidance for Industry – Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report.
8) SOP Version
Version 1.0
