Pharmacovigilance Systems and Strategies: Importance of Post-Marketing Surveillance for Ensuring Drug Safety and Patient Health in Europe, United States, and India

After a drug is granted a marketing license, its post-marketing surveillance is evaluated to ensure that it is continuously monitored for undesirable effects. This monitoring is achieved through an effective Pharmacovigilance system. In our review, we discuss the Pharmacovigilance systems of Europe, the United States, and India, along with several examples of effective Pharmacovigilance strategies, such as the Tracleer® Access Programme and Tracleer® Excellence programs for Bosentan, Merck’s Worldwide Adverse Experience System, the European and United States Varicella Zoster Virus Identification Programs for Varivax, the Siddha Initiative for Documentation of Drug Adverse Reaction, an android mobile app for AYUSH Pharmacovigilance, and the Global Pharmacovigilance Database by Sanofi Pasteur. This report demonstrates the importance of post-marketing surveillance in detecting rare adverse experiences that may go unnoticed during clinical trials. It also emphasizes the significance of highlighting the field of Pharmacovigilance to improve patient safety and offer them the best possible quality of life.