CHALLENGES IN SAFETY REPORTING PHARMACEUTICAL COMPANIES STANDPOINT IN DRUG SAFETY

Pharmacovigilance plays an essential role in protecting patients by identifying, evaluating, understanding, and preventing adverse effects associated with medicines. Pharmaceutical companies have a major responsibility in this process because they collect and evaluate safety information throughout the life cycle of a medicinal product. Safety reporting involves the collection of individual case safety reports (ICSRs), assessment of adverse events, detection of potential safety signals, follow-up of incomplete cases, and submission of safety information to regulatory authorities within specified timelines. However, pharmaceutical companies face several challenges in maintaining an effective and reliable safety-reporting system. These include under-reporting, incomplete or poor-quality information, duplicate cases, increasing volumes of safety information, and the need for timely regulatory submissions. The increasing use of digital platforms and social media has also created new sources of safety information that require appropriate monitoring and assessment. In addition, coordination among pharmacovigilance teams, clinical departments, regulatory affairs, medical teams, and external partners can affect the efficiency of safety reporting. Technological developments such as automation, artificial intelligence, natural language processing, and advanced data-management systems may help companies manage these challenges more efficiently. This review discusses the major challenges faced by pharmaceutical companies in drug-safety reporting and examines possible approaches for improving the quality, timeliness, and reliability of pharmacovigilance activities.