Post-marketing regulatory actions in Portugal-A retrospective analysis between 2013 and 2023.

Abstract

BackgroundThe safety of medicines is a critical public health concern that requires continuous monitoring and evaluation throughout a drug's lifecycle, including post-authorization. Over the past decade, Portugal has undergone significant changes in its pharmaceutical sector, driven by regulatory actions from the National Authority of Medicines and Health Products (INFARMED, I.P.), which ensures the safety, effectiveness, and quality of medicines.ObjectiveThis study aimed to analyze the regulatory actions taken due to safety concerns in Portugal from 2013 to 2023.MethodsA retrospective analysis was conducted using safety alerts published by INFARMED, I.P. between January 2013 and December 2023. The analysis focused on changes in marketing status, drugs involved, causes of regulatory actions, and yearly patterns.ResultsDuring the study period, 602 safety and quality alerts were issued, being 41 from safety and 561 from quality. The highest number of regulatory actions occurred in 2018, with 172 cases (28.57%). Generic drugs accounted for the majority, with 432 cases (72.19%). Batch recalls (76.65%) corresponded to the main regulatory action related to quality. Quality alerts were often related to impurities or stability (65.42%), non-conformity with GMP standards (11.76%), and labeling or packaging problems (10.70%). Unfavorable risk-benefit ratios were the cause of 100% of safety-related alerts.ConclusionsThe findings highlight the importance of robust surveillance systems and continuous evaluation of manufacturing and regulatory processes to enhance drug safety. Collaboration between regulators, the pharmaceutical industry, and healthcare professionals is essential to ensure that the benefits of medicines consistently outweigh the risks associated with their use.