Overcoming Roadblocks in Global Pharmacovigilance Harmonization
Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Global Pharmacovigilance Harmonization, on the other hand, refers to the process of aligning regulations, practices, and standards across countries and regions in order to facilitate global collaboration and the cross-border exchange of information. However, achieving this goal is challenging due to the diversity of regulatory environments and scientific advancements. Identifying Roadblocks to Pharmacovigilance Harmonization Achieving global harmonization in PV is crucial for reliable drug safety monitoring. However, this process is hindered by several barriers, including inconsistent regulatory requirements and cultural differences that influence how PV activities are implemented. Differing Regulatory Requirements Every country has the...