The study titled "Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations" emphasizes the importance of a robust pharmacovigilance (PV) system to ensure the safe and effective use of medicines. The research underscores that national regulatory authorities (NRAs) must establish and maintain a PV system, outlining the responsibilities of stakeholders, including marketing authorization holders (MAHs). The study highlights that while many countries have PV systems, their maturity varies, with some just beginning their development. The World Health Organization (WHO) offers a Global Benchmarking Tool to help NRAs evaluate their PV systems. The European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has formulated consensus recommendations aligned with harmonized standards for the development and phased implementation of essential PV system components. These recommendations aim to guide countries, especially those with limited resources, in establishing or enhancing their PV systems.
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