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The Quality Quotient: Rethinking PSURs for Regulatory Excellence
Rose Coley1, Andrea Rau2, Karen Doolittle3
1Clinical Safety & Pharmacovigilance, Moderna, Inc., 325 Binney Street, Cambridge, MA, 02142, USA. rose.coley@modernatx.com.
Therapeutic Innovation & Regulatory Science
|April 30, 2025
Summary
The Periodic Safety Update Report (PSUR) Quality Metric enhances safety reporting for medicinal products. This tool ensures data quality and regulatory compliance, driving continuous improvement in submissions.
Area of Science:
- Pharmacovigilance
- Regulatory Science
- Drug Safety
Background:
- Regulatory Authorities require high-quality safety reporting for marketed medicinal products.
- The Periodic Safety Update Report (PSUR) Quality Metric was developed to address this need.
- The metric aims to evaluate, measure, and enhance PSUR quality for continuous improvement.
Purpose of the Study:
- To introduce and describe the PSUR Quality Metric.
- To outline its role in ensuring the quality of safety data submitted to Regulatory Authorities.
- To highlight its function in identifying areas for improvement in PSURs.
Main Methods:
- A comprehensive method was established for the PSUR Quality Metric.
- This involved analyzing feedback from Regulatory Authorities.
- Quality-related comments were categorized and a scoring system was applied.
Main Results:
- The PSUR Quality Metric promotes transparency and regulatory compliance.
- It ensures Marketing Authorization Holders actively monitor and improve safety data quality.
- The metric supports the tracking and enhancement of submitted safety data.
Conclusions:
- The PSUR Quality Metric offers a structured framework for high data quality and regulatory compliance.
- It fosters a culture of quality and supports regulatory excellence.
- Systematic evaluation and actionable feedback are key components of the metric.
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