Clinical trials and pharmacovigilance

Pharmacovigilance (PV, or PhV), also known as drug safety, is the discipline within pharmaceutical science that addresses the identification, evaluation, and mitigation of adverse effects and other drug-related problems associated with pharmaceutical products.
The term ‘pharmacovigilance’ is derived from the Greek pharmakon (meaning ‘drug’) and the Latin vigilare (meaning ‘to keep watch’), reflecting the discipline’s focus on monitoring drug safety.” Adverse drug reactions (ADRs), which are harmful and unintended responses to approved medicinal products, are a central focus of pharmacovigilance. That definition includes lack of efficacy: that means that the doses normally used for prevention, diagnosis, or treatment of a disease—or for the modification of physiological disorder function. In 2010, the European Union expanded the definition to include lack of efficacy and medication errors, recognizing that adverse outcomes extend beyond harmful responses to therapeutic failures and misuse. The U.S. Food and Drug Administration (FDA) adopted similar expanded criteria for its pharmacovigilance framework, which includes medication errors, overdose, misuse, abuse, and exposure during pregnancy or breastfeeding. Patient and healthcare provider reports (via pharmacovigilance agreements or national mandated reporting laws), as well as other sources such as cases reported in medical literature, play a critical role in providing the data necessary for pharmacovigilance to take place. In many regulatory systems, including those of the United States and European Union, marketing authorization holders are required to submit adverse event reports to national drug regulatory authorities as part of post-approval safety monitoring (See Adverse event reporting below.)
Pharmacovigilance seeks to detect and evaluate patterns of adverse outcomes—known as safety signals—and to support actions that reduce patient risk from marketed medicinal products. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with local, regional, national, or international laws and regulations. This includes ongoing collection of safety data after a product is approved for marketing.