Abstract
Pharmacovigilance plays a crucial role in ensuring the safety of medicinal products throughout their lifecycle. With the growing complexity of pharmaceutical development and the increasing global use of medications, regulatory authorities have emphasized proactive strategies for identifying and managing drug-related risks. Risk Management Plans (RMPs) have emerged as essential tools in modern pharmacovigilance systems, providing structured approaches for identifying potential safety concerns, monitoring adverse drug reactions, and implementing risk minimization measures. Over the past two decades, regulatory frameworks such as the European Union Risk Management Plan (EU-RMP) and the United States Food and Drug Administration’s Risk Evaluation and Mitigation Strategies (REMS) have significantly strengthened global drug safety monitoring. Despite these advancements, several challenges remain in the effective implementation of RMPs, including variations in regulatory requirements across regions, limitations in real-world safety data, underreporting of adverse drug reactions, and difficulties in evaluating the effectiveness of risk minimization strategies. Additionally, the increasing globalization of pharmaceutical markets has created a need for greater harmonization of pharmacovigilance practices among regulatory authorities. Emerging technologies such as artificial intelligence, big data analytics, and real-world evidence are expected to play an important role in improving signal detection and strengthening risk management systems. This review discusses the evolution of Risk Management Plans in global pharmacovigilance, outlines their key components and regulatory frameworks, examines the major challenges associated with their implementation, and highlights future perspectives aimed at enhancing drug safety monitoring and patient protection.