A review of pharmacovigilance

Abstract

Introduction: Pharmacovigilance involves more than spontaneous reporting, and is more than just evaluating marketed medications. It has grown from a minor component of drug control to a major activity and expanded its scope to encompass the assistance for patient safety during clinical trials by ensuring adequate informed consent and institutional review boards (ethical committees); development of a safety profile for proper use of a new molecular entity and appropriate communication of that information to a range of relevant stakeholders; selection of the first safe dose for use in humans based on pharmacologic data obtained in animal studies; development of a safety profile. This study implicates the growth of pharmacovigilance in assessing the safety of drugs. Methods: The subsequent information was obtained by reviewing the data from earlier published material. The obtained information was evaluated, compiled, deconstructed, reassembled, interpreted, and conclusions were reached. Results: The supply of data necessary for assessing the advantages and dangers of medicines is, first and foremost, a scientific task. Good pharmacovigilance practice must be created to guarantee that data is gathered and used correctly for the intended purpose. Conclusion: Pharmacovigilance has grown into an essential part of drug control. Signal management protocols ensure that surveillance operations monitor the produced product through collaborative actions with manufacturing specialists, analyze benefit-risk management and inspection readiness maintenance as a corporate culture process.

Analysis of the activity of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in the field of clinical trials, registration of medicinal products and monitoring of adverse drug reactions in 2017-2021

“…Regardless of the registration path, in each case the registration of a medicinal product is preceded by a careful analysis of efficacy and safety (determination of a positive benefit-risk ratio) of the tested drug, which is demonstrated in the course of preclinical trials and phase I-III clinical trials [1,2]. The moment of drug registration and its introduction to the pharmaceutical market after the successful completion of Phase III does not terminate the drug research, but initiates the fourth, still ongoing, phase of clinical trials, focusing on continuous monitoring of the safety of drugs on the market ("pharmacovigilance") [3,4]. Each stage of drug research is defined in detail by relevant legal regulations.…”