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 their own set of guidelines for PV reporting and compliance. For example: 

• The European Union relies on EudraVigilance for adverse event reporting. 

• The United States uses the FDA Adverse Event Reporting System (FAERS). 

• India has its Pharmacovigilance Programme under the Central Drugs Standard Control Organization (CDSCO). 

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