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Year: 2025
Issue: 4
Volume: 103
Author Names: Sonia Bianca BLAJ
Abstract: The main objective of pharmacovigilance is to monitor drug safety. Based on this aspect, it can be said that the pharmacovigilance system is in a continuous process of adaptation, including from the perspective of the complex regulatory framework that applies in this area. This study identifies and presents the main international, European, and national regulations applicable to the analysis of the legal framework for pharmacovigilance, while also highlighting the need for legislative harmonization to better protect public health. Because health protection is a positive obligation of the state, in order to ensure a balance between patient care and the possibility for patients to benefit as quickly and efficiently as possible from drug therapy, continuous efforts are being made to harmonize pharmacovigilance legislation
DOI: https://doi.org/10.62838/cjjc-2024-0064
Pages: 94-100