In the therapy development process, the regulator is the government authority or agency that determines when and how a therapy is allowed to be commercially available to patients outside of research settings. Regulators are responsible for protecting public health. A regulatory authority may specify requirements for quality, safety, and effectiveness to be demonstrated for a therapy before granting marketing authorization and may have additional requirements to keep the product on the market.
The U.S. Food and Drug Administration (FDA) is the regulatroy agency in the United States. Other regulatory agencies include the European Union European Medicines Agency (EMA), and Japan’s Pharmaceutical and Medical Device Agency (PMDA).