What is it about?
This retrospective study analyzed all safety and quality alerts issued by the Portuguese National Authority of Medicines and Health Products (INFARMED, I.P.) between 2013 and 2023. A total of 602 alerts were reviewed, including 41 safety-related and 561 quality-related notifications. Most alerts involved generic medicines and oral solid forms. The main reasons for regulatory actions included impurities, stability problems, and non-compliance with Good Manufacturing Practices (GMP). The year 2018 registered the highest number of alerts, largely due to contamination incidents involving valsartan products.
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Why is it important?
Post-marketing surveillance is essential to ensure that medicines remain safe and effective after reaching the market. This study is the first to combine both safety and quality alerts over a decade in Portugal, providing an overview of regulatory trends and common causes of drug recalls. By identifying recurrent issues—such as impurities, labeling errors, and GMP violations—it highlights areas where pharmaceutical manufacturing and regulatory oversight can improve. The findings support stronger collaboration between regulators, manufacturers, and healthcare professionals to safeguard public health.
Perspectives
This paper shows how transparent regulatory communication and robust quality control can protect patients and reinforce trust in medicines. Continuous monitoring of drug quality is as critical as assessing their clinical safety. I hope these findings encourage proactive pharmacovigilance and quality assurance practices, both nationally and across Europe, to ensure that every medicine on the market truly meets the highest standards of safety and efficacy.
PhD João José Joaquim
Instituto Politecnico de Coimbra
Read the Original
This page is a summary of: Post-marketing regulatory actions in Portugal—A retrospective analysis between 2013 and 2023, International Journal of Risk & Safety in Medicine, November 2024, SAGE Publications,
DOI: 10.1177/09246479241301250.
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