Pharmacovigilance and Marketing Authorizations Holders of Pharma pdts

Abstract

In modern healthcare, pharmacovigilance (PV) offers critical advantages that impact pharmaceutical products throughout their life cycle. Modern health care benefits significantly from the practice of pharmacovigilance, which monitors drug safety and efficacy throughout the product life-cycle (1). Although a pharmaceutical product is rigorously tested prior to approval, unforeseen side effects may arise after authorization due to insufficient sample size, length, and heterogeneity of studied populations (2). This phenomenon is responsible for long-term and rare side effects of drugs being identified only after they have been widely prescribed (3). As such, post-marketing surveillance is critical for protecting public health (4). The decision of a regulatory authority to authorize a medicine is a marketing authorization that rests on an assessment that the proposed drug's advantages outweigh its risks for a particular indication and in a particular patient group (5). The U.S. Food and Drug dministration (FDA), the European Medicines Agency (EMA), and the Central Drugs Standard ontrol Organization (CDSCO) in India mandate that Marketing Authorisation Holders (MAHs) maintain vigilance for adverse effects of approved drugs, report novel safety issues, implement appropriate pharmacovigilance mechanisms, and update relevant product literature with information on new risks (6,7). Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) are required, ensuring a continuous risk–benefit evaluation throughout the product life cycle (8,9). Modern pharmacovigilance systems collect data from multiple sources including spontaneous reports of adverse drug reactions (ADRs), electronic health records, registries, health insurance claims data, real-world evidence, and direct patient reports, which contribute to increased quantity and diversity of safety information (10). However, an overwhelming number of ADRs are reported globally, necessitating enhanced reporting mechanisms and training (11). Technologies such as artificial intelligence, machine learning, and Big Data Analytics have revolutionized the pharmacovigilance system by enhancing signal detection and risk evaluation (12). Several challenges including inadequate reporting rates, quality of information, diverse regulatory systems globally, and insufficient infrastructure in developing countries have hampered the efficacy of pharmacovigilance systems. The system has evolved beyond mere reporting to a holistic life-cycle concept to track medicines safety, enabling continuous evaluation of the benefit–risk profile and protection of patients against harm (14). Close partnership of regulators, healthcare providers, pharmaceutical companies, and patients remains key to sustaining public confidence in medicines and raising global healthcare safety standards (15).