IND is the abbreviation of Investigational New Drug, which refers to the approval of clinical research of new drugs. The production of new drugs requires two administrative approvals, one is in the clinical research phase (IND application), and the other is the completion of the clinical research registration (NDA application). Medicilon is the first CRO to offer preclinical animal testing service for the global pharmaceutical companies in China. We provide the IND application for the preclinical services. Clinical research refers to a drug that is tested on humans after animal testing. It is divided into phase I, phase II, and phase III clinical trials. Each phase of clinical trials has different test purposes. Among them, phase III clinical trials have the largest number of people. The most critical.
NDA is the abbreviation of New Drug Application, which refers to the stage of application for registration and marketing of a new drug after clinical trials. The production of innovative drugs needs to go through five stages, which are the compound preparation stage, preclinical research, clinical research, marketing registration, and new drug monitoring. After the clinical research, there is a handicap before the drug is marketed, which is to prepare materials according to the requirements and carry out the registration and marketing application (NDA application). After the NDA declaration, the drug can be marketed only after it has been approved.
The above are the two administrative approvals that must be carried out for the creation of new drugs (innovative drugs). Not only does the marketing of innovative drugs require approval, but also the approval of generic drugs, but the application process for generic drugs is much simpler.
ANDA is the abbreviation of Abbreviated New Drug Application, that is, generic drug NDA declaration. Generic drugs are copies of innovative drugs. Generic drugs must also undergo NDA declarations. However, generic drugs do not need to undergo clinical trials, and only need to prove that their quality and efficacy are consistent with the original drugs. Therefore, his NDA declaration is much simpler, that is Abbreviated in ANDA is short and concise.
The above is the relevant introduction of the FDA’s new drug application process. In short, IND application is to declare to the authorities for clinical trials; NDA application is to report to the authorities for drug registration and marketing; and ANDA application refers to the application for registration and marketing of generic drugs. In practice, related abbreviations are often used, such as IND drugs, which are drugs in the clinical research phase; NDA number, which is the number of drugs that are being declared for marketing. Knowing the meaning of related abbreviations will help you better communicate with your peers.