A Risk-Based Approach for Safety Case Follow-up of Adverse Event Reports in Pharmacovigilance.

This study presents an analysis of follow-up attempts for adverse event (AE) reports, shedding light on the characteristics of a risk-based approach to Individual Case Safety Report (ICSR) follow-up by Marketing Authorization Holders (MAH). The analysis primarily focuses on Spontaneous Reports (SR), reports from Patient Support Programs (PSPs), and literature, utilizing data from safety reports sourced from the European Economic Area (EEA) during the pre-pandemic period. Through descriptive statistics, we examine response rates spanning 1 year and compare various types of cases based on distinct ICSR features, including serious vs non-serious, listed vs unlisted, suspected vs not-suspected, SR vs PSP vs literature, as well as comparisons between different product categories (innovator, biological, generics, and combinations).

Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

Purpose: Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas.

Methods: All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies.