The Generic Drug Approval Process

This chapter provides a high-level overview of the concepts behind generic drug development, submission, and approval. The ANDA pathway was created for drug products that are the "same as" the branded drug, meaning it has identical active ingredient(s), dosage form, strength, route of administration, and conditions of use as the branded product. The identification, choice of, and comparison to the branded product is the beginning of the generic drug development process. ANDAs must comply with the requirements of the common technical document (CTD) format developed at the International Conference of Harmonisation and common to any drug application in the United States, Europe, and Japan. At a high level, the CTD is comprised of the following modules with specific highlights to follow: administrative information and prescribing information; summaries; quality; nonclinical; and clinical.