PharmacovigilanceSysteme

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Its primary goal is to ensure the safe use of medicines and to minimize risks while maximizing benefits. Pharmacovigilance encompasses post-marketing monitoring, adverse event reporting, signal detection, causality assessment, risk assessment, and risk management.

Data sources include spontaneous adverse event reports from healthcare professionals and patients, electronic health records, claims data, clinical trial data, and published literature. Key processes are signal generation and validation, cause-and-effect assessment, and the evaluation of the benefit–risk balance. When signals are confirmed, regulators may require risk minimization measures, labeling changes, safety communications, or, in rare cases, withdrawal of a product.

Regulatory frameworks: pharmacovigilance is governed by national authorities in partnership with international bodies. The World Health Organization coordinates the Programme for International Drug Monitoring, and guidelines from the ICH and CIOMS shape modern practice. In the European Union and United States, manufacturers are required to implement pharmacovigilance systems, maintain a pharmacovigilance system master file, and develop risk management plans.

In practice, pharmacovigilance operates across the medicine life cycle, including pre-approval clinical trials and post-market surveillance. It relies on proactive reporting, signal management, and transparent risk communication to healthcare professionals and the public. The overarching aim is to protect public health by ensuring medicines’ safety profiles are well understood and that therapeutic benefits continue to outweigh risks.