Implementation of PRAC Periodic Safety Update Report Single Assessment (PSUSA): Recommendations for NAPs at National Regulatory Level in the EU

Background/Introduction: Through the PSUSA procedure, new safety data provided by marketing authorization holders (MAHs) for a specific active substance is periodically assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). Based on this assessment, the PRAC may provide recommendations with the aim of mitigating potential risks, thereby ensuring that the benefit-risk balance of medicines containing the concerned active substance remains favourable in the post-marketing setting [1,2]. A review of the product information (PI) was performed for a group of medicines to understand the extent to which MAHs comply with the European Union good pharmacovigilance practice (EU-GVP) guidelines with regards to implementing the PRAC PSUSA recommendations at national regulatory level. Objective/Aim: Describing the extent and the time frame in which the PSUSA recommendations provided by the PRAC are implemented at the national regulatory level in EU Member States (MS). Methods: A sample of 87 PSUSA reports on nationally authorized products (NAPs) containing active substances with ATC-code L01 (antineoplastic agents), published between July 2012 and December 2020, was retrieved and reviewed from EMA databases [3]. In case the outcome of the procedure was to vary the marketing authorization (MA), the PI of the concerned medicines were appraised to assess (1) compliance to recommendations and (2) time to the full implementation of the recommendations. In this context, 10 EU MS were selected based on their geographic location and area in a way to represent all EU MS in the study. Data-analysis was performed using descriptive statistics. Results: The extent to which the recommendations were fully implemented were 42.5% for southern, 62.8% for western, 62.7% for northern, 44.9% for eastern and 47.5% for the central part of Europe. On the other hand, the extent of the full implementation seemed to be comparable between small and large MS: 54.1% versus 49.0%. Furthermore, the average time to implementation was 9.3 months for Summaries of Product Characteristics (SmPCs) and 9.4 months for package leaflets (PLs). Conclusion: The findings show that the extent of the full implementation of the recommendations vary among different EU regions, while the difference between small and large MS is negligible. Overall, a relatively low compliance to the recommendations and a long time to implementation has been observed at the national lev