Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use

Abstract

Purpose: The article provides an overview of the European Union Incident Management plan (EU-IMP) and reviews its first 10 years of operation. It outlines its scope, objectives, triggers, principles, and components. Methods: Records were extracted from the European Pharmacovigilance Issues Tracking Tool and a separate tracking system for the period August 20, 2009 to August 19, 2019. Results: During the 10 years of observation, 78 incidents were reviewed by the Incident Review Network and addressed through routine measures. Their number has varied throughout the years with a significant decrease after 2012. Incidents mainly covered safety (56%) and quality (34%) issues or a combination thereof (5%). The majority (70%) were notified by EU regulators and involved centrally and nationally authorized product in similar proportions. A referral was recommended as the assessment pathway for 47% of the issues while lines-to-take were the most frequent communication measure (the sole measure in 65% cases). Forty-six per cent of the issues resulted in a variation, whereas 22% resulted in maintenance of the marketing authorization. Conclusion: The EU-IMP is underpinned by a robust regulatory framework with defined processes and clear roles and responsibilities and offers a platform to coordinate actions and communication at EU level, rapidly pool expertise, minimize duplications, and address public health incidents.