pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug‑related problems. It aims to improve patient safety and public health by monitoring medicines throughout their lifecycle, from clinical development to post‑marketing use. The field combines data collection from spontaneous reports, electronic health records, clinical studies, and registries, employing statistical and clinical methods to identify signals of potential harm.

Regulatory agencies such as the U.S. Food and Drug Administration, European Medicines Agency, and World Health Organization coordinate national and international pharmacovigilance systems. Companies are required to submit periodic safety update reports and to act promptly on new safety information. Spontaneous reporting by healthcare professionals and patients remains a cornerstone, complemented by active surveillance programs and risk‑management plans that outline specific measures to mitigate identified risks.

Key processes include case intake and validation, data coding using standardized terminologies, signal detection through disproportionality analysis, and causality assessment. When a signal is confirmed, regulatory actions may range from label updates and restricted use to market withdrawal. Communication of risk information to clinicians, patients, and the public is integral to the system.

Challenges in pharmacovigilance involve under‑reporting, data quality, and the need to interpret complex multi‑drug interactions. Advances in big‑data analytics, artificial intelligence, and real‑world evidence are expanding the ability to detect rare and delayed adverse events more rapidly. Ongoing international collaboration seeks to harmonize methodologies, improve data sharing, and strengthen global drug safety monitoring.