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Year: 2026
Issue: 3
Volume: 106
Author Names: Sonia Bianca BLAJ
Abstract: The pharmacovigilance system was designed and developed to ensure better monitoring of adverse drug reactions, with the aim of safeguarding patients’ right to health. This reporting process begins as early as the clinical trial phase and continues after the drug is marketed through ongoing monitoring. Research in this field has highlighted underreporting of adverse drug reactions, even though reporting can now be done not only by healthcare professionals but also by patients. This study aims to analyze the legal nature of the reporting obligation, the factors influencing underreporting, and the impact of regulations on this phenomenon. Furthermore, a key issue that needs to be debated in this context is whether this failure to report adverse reactions could give rise to legal liability.
DOI: https://doi.org/10.62838/cjjc-2024-0089
Pages: 58-64