Biomedicine & Pharmacotherapy

Pharmacovigilance and Drug Regulation

Pharmacovigilance and drug regulation focus on monitoring, evaluating, and ensuring the safety and efficacy of therapeutic agents throughout their lifecycle, from development to post-marketing. Pharmacovigilance systems detect, assess, and prevent adverse drug reactions, drug-drug interactions, and medication errors. Current challenges include underreporting of adverse events, variability in regulatory standards across regions, and the need for timely analysis of large datasets from diverse populations. Integration of electronic health records, real-world data, and digital health tools enables more efficient identification of safety signals. Regulatory frameworks mandate compliance with Good Clinical Practice, Good Manufacturing Practice, and international guidelines to ensure quality, safety, and efficacy. Emerging trends include the use of artificial intelligence and machine learning to analyze pharmacovigilance data, predictive toxicology to anticipate adverse events, and personalized risk assessment based on genetic and phenotypic profiles. Post-marketing surveillance, risk management plans, and communication strategies ensure continuous monitoring and rapid response to safety concerns. Collaboration among regulatory authorities, pharmaceutical companies, and healthcare providers strengthens the global pharmacovigilance network. By combining rigorous safety assessment, data-driven monitoring, and regulatory oversight, pharmacovigilance and drug regulation safeguard public health, optimize therapeutic outcomes, and maintain trust in pharmacotherapy, while addressing the complexities of increasingly personalized and biologically sophisticated medicines.