ABSTRACT
A generic pharmaceutical or an abbreviated new drug application (ANDA) is “abbreviated” since it typically does not need to show safety and effectiveness using preclinical (animal) and clinical (human) data, only that it must be equivalent to existing branded drugs. The ANDA medication was created as a low-cost alternative for the public when the patent on novel compounds expired. A generic drug has a sizeable market, and India leads the generic drug market. Each nation has its own regulatory body, such as the CDSCO in India, the European Directorate for the Quality of Medicines & Health Care (EDQM) in Europe, and the United States Food and Drug Administration (FDA) in the US. This chapter includes the authorisation for selling in India, Europe, and the US, as well as the regulatory approval process. Utilising a common technical document (CTD) format, which harmonises various regulatory requirements, the ANDA is filed in each country's designated format. We also talk about how regulatory clearances and associated paperwork differ in India, Europe, and the US for generic medications.
