Guidelines for Pharmacovigilance Development Safety Update Reports (DSUR)
1) Purpose
The purpose of this SOP is to outline procedures for the preparation, review, and submission of Development Safety Update Reports (DSURs) in pharmacovigilance.
2) Scope
This SOP applies to pharmacovigilance personnel responsible for the preparation, review, and submission of DSURs within the organization.
3) Responsibilities
The Pharmacovigilance (PV) Manager is responsible for overseeing DSUR preparation and submission. PV staff involved in DSUR activities are responsible for adhering to this SOP.
4) Procedure
4.1 DSUR Preparation
- Identify medicinal products requiring DSUR submission based on regulatory requirements and development phase.
- Collect and compile safety data, including adverse event reports, safety findings, and risk assessments, for inclusion in the DSUR.
4.2 DSUR Content
- Define the structure and content requirements for DSURs, including sections on product development status, safety data updates, and risk-benefit assessment.
- Ensure that DSURs comply with regional regulatory requirements, such as those outlined in ICH guidelines and local pharmacovigilance regulations.
4.3 DSUR Review
- Conduct internal review and quality assurance checks to ensure accuracy, completeness, and consistency of DSUR content.
- Seek input and approval from relevant stakeholders, including clinical development teams, regulatory affairs, and medical experts.
4.4 DSUR Submission
- Prepare DSURs for submission to regulatory authorities according to specified timelines and regional requirements.
- Document DSUR submission processes, including tracking and confirmation of receipt by regulatory agencies.
4.5 DSUR Follow-up
- Respond promptly to requests for additional information or clarification from regulatory authorities regarding submitted DSURs.
- Monitor regulatory updates and requirements related to DSUR submission and incorporate changes into future DSUR preparations.
4.6 Documentation and Record Keeping
- Maintain comprehensive records of DSUR preparation, review, submission, and correspondence with regulatory agencies.
- Ensure that all DSUR documentation is stored securely and is accessible for regulatory inspections and audits.
4.7 Training and Education
- Provide training to PV staff on DSUR requirements, preparation processes, and regulatory expectations.
- Ensure that PV team members are knowledgeable about pharmacovigilance guidelines and best practices related to DSUR preparation and submission.
4.8 Continuous Improvement
- Regularly review DSUR procedures and templates based on feedback, regulatory changes, and inspection findings.
- Implement improvements to streamline DSUR preparation, enhance data quality, and ensure compliance with evolving regulatory requirements.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, DSUR – Development Safety Update Report
6) Documents, if any
DSUR templates, safety data summaries, regulatory guidelines, training materials.
7) Reference, if any
ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VII – Periodic Safety Update Reports (PSURs).
8) SOP Version
Version 1.0
