It is the Japanese equivalent to a U.S. IND (investigational new drug) application; to the Koseisho, the Japanese equivalent of the U.S. Food and Drug Administration (FDA).
An application which must be approved by the FDA before any new drug is marketed to the general public which provides information designed to demonstrate safety and effectiveness ness. Once the application is approved, the drug may be prescribed by any physician or other health professional authorized to prescribe under State law. The NDA must include: reports of animal and clinical investigations; a list of ingredients including the active drug and any vehicle, excipient, binder, filler, flavoring, and coloring; a description of manufacturing methods and quality control procedures: samples of the drug; and the proposed labelling. Approval of an NDA must be based on valid scientific evidence that the drug is safe, and adequate and well-controlled clinical studies (such as random controlled trials) demonstrating that it is effective for its intended, i.e., labeled, uses. NDA also commonly refers to the FDA’s approval of an application, i.e., the manufacturer’s license to market the drug.
An application requiring approval by the Food and Drug Administration before any new drug is marketed to the general public. Before approval, the manufacturer must provide the FDA with scientifically acceptable evidence of the new drug’s safety and efficacy.