ABSTRACT
Submitting a New Drug Application (NDA) to the FDA and to other international agencies requires a meticulous, well-indexed, comprehensive, and readable prepared document. In the United States, the applicant's responsibility is to submit data that will satisfy the U.S. requirements of the Food, Drug, and Cosmetic Act, the Code of Federal Regulations (CFR), and the International Committee on Harmonisation (ICH) guidelines. In the European Union where a Sponsor intends to register their pharmaceutical products, the European Directives must be adhered to along with the ICH guidelines. In addition to these requirements, as of January 2008, the FDA in cooperation with ICH indicated that all NDAs are to be submitted in an electronic Common Technical Document (eCTD) format following the ICH M2 and M4 guidelines for Modules 1, 2, 3, 4, and 5 (1). These ICH guidelines specify the format for the presentation of generated data on Safety, Efficacy, and Quality for all international new product submissions (2). The United States, European Union, and Japan regulations are very similar on what should be submitted in a new product application. The only difference is for specific requests that must be addressed according to each countries requirement for the submission of new product applications (see chap. 24).
