Since 2020, aggregated from related topics
Pharmaceutical regulation refers to the process of overseeing the development, production, distribution, and marketing of pharmaceutical products to ensure their safety, efficacy, and quality. This involves the establishment of rules, standards, and guidelines by regulatory agencies such as the Food and Drug Administration (FDA) in the United States, and the European Medicines Agency (EMA) in Europe. Pharmaceutical regulation plays a crucial role in protecting public health by ensuring that medicines are safe and effective for use by patients. It also aims to prevent fraud, misbranding, and the distribution of counterfeit or substandard drugs in the market. Regulatory requirements often include pre-market approval of new drugs, post-market surveillance, inspections of manufacturing facilities, and labeling and advertising restrictions. Compliance with these regulations is essential for pharmaceutical companies to bring their products to market and maintain their licenses to operate.