Safety and Pharmacovigilance in the Lifecycle of Medicinal Products
摘要
Pharmacovigilance is crucial for monitoring drug safety throughout the lifecycle of medicinal products. It encompasses pre-market and post-market surveillance, identifying and mitigating adverse drug reactions (ADRs) to ensure patient safety. The discipline evolved in response to major safety incidents, such as the thalidomide crisis, prompting the establishment of global regulatory frameworks. Pharmacovigilance integrates real-world evidence, digital tools, and artificial intelligence to improve signal detection and risk management. Regulatory agencies, including the FDA, EMA, and WHO, enforce compliance through reporting requirements and risk management plans. Continuous monitoring, transparent communication, and ethical responsibility remain fundamental to pharmacovigilance efforts.