A Review on: Evolution and System of Pharmacovigilances

Pharmacovigilance is the science dedicated to detecting, assessing, understanding, and preventing adverse drug reactions (ADRs) and other drug-related problems, which has become an essential part of ensuring drug safety and public health. Over the decades, pharmacovigilance has evolved from a predominantly reactive system focused on post-marketing surveillance to a more comprehensive, proactive approach that engages multiple stakeholders, including regulatory authorities, healthcare professionals, pharmaceutical companies, and patients. This review explores the historical evolution of pharmacovigilance, highlighting key milestones such as the establishment of pivotal regulatory bodies like the U.S. FDA, European Medicines Agency (EMA), and the UK's MHRA, which laid the foundation for modern drug safety practices. Programs like MedWatch, EudraVigilance, and the Yellow Card Scheme were developed to support the surveillance of drug safety after market approval, enabling early detection of ADRs and the implementation of corrective actions. The review further examines the systems that have shaped pharmacovigilance today, emphasizing the shift from spontaneous reporting systems to more advanced methods like signal detection, risk management, and global data sharing. Moreover, the involvement of multiple stakeholders in pharmacovigilance processes is explored, with an emphasis on the role of pharmaceutical companies in maintaining safety profiles, healthcare providers in identifying and reporting ADRs, and patients in directly contributing to the safety reporting process. The integration of advanced technologies such as artificial intelligence and big data analytics is also discussed as key drivers in the evolution of pharmacovigilance, facilitating more efficient safety monitoring. This review underscores the significance of an integrated, collaborative, and transparent pharmacovigilance system that continues to evolve in response to the growing complexity of drug therapies and healthcare systems globally.