Risk-Benefit Balance

The Risk-Benefit Balance is an assessment that weighs the positive therapeutic effects of a medicinal product against the potential risks associated with it. These risks encompass aspects related to the quality, safety, and efficacy of the medicinal product concerning the health of patients or public health in general. Evaluating the risk-benefit balance is a fundamental part of the regulatory process in the pharmaceutical industry, helping to determine whether the benefits of a medication outweigh its potential risks and whether it should be authorized for use.