ABSTRACT
Approval for New Drug Applications (NDA), also known as Investigational New Drug Applications (INDA), regulated by Drugs and Cosmetics Act of 1940 and Rules of 1945. Substances that are defined in Section 3b of the Drugs and Cosmetic Act are recognized as drugs and have been granted registration for the purposes of manufacturing, storing, importing, and other activities. Both the NDA and the INDA have a broad definition of when new medications are being considered. Consideration with regard to both the NDA and the INDA is given to any new discoveries, variations of already-approved pharmaceuticals (including variations of drug combinations), variations in dose, extra strength, and new claims for already-approved drugs. The required documents vary depending on the applications, but, for the majority of cases, they all include fundamental information regarding the drugs as well as data on their safety and clinical trials. The use of a Common Technical Document (CTD) is mandated to ensure that regulatory data are standardised and that protocols are harmonised. The majority of countries have agreed to use the CTD protocol as a uniform operating system for the approval procedure. Detailed information regarding the requirements and process for INDA and NDA approval can be found in this chapter.
