Journal of Pharmaceutical Care & Health Systems
Open Access

Drug Regulatory Affairs

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. Wiki: Regulatory Affairs is a profession within regulated industries, such as pharmaceuticals, medical devices working with such agencies as the Food and Drug Administrationor European Medicines Agency. Advising their companies on the regulatory aspects and climate that would affect proposed activities. Regulatory affairs specialists focus on ensuring organizations are meeting all of the applicable regulations, such as those established by the Food and Drug Administration, for products and services. These specialists do so by completing and filing paperwork with the appropriate local, state, and federal agencies.