What is an ind statement?

IND is the abbreviation of Investigational New Drug, which refers to the clinical research review of new drugs. The occurrence of new drugs must complete two administrative examination and approval systems, one is in the clinical research link (IND declaration), and the other is to apply for clinical research registration and listing (NDA declaration). Clinical research refers to the experiment of drugs on human body after small animal experiments, which is divided into phase I, phase II and phase III clinical research. Each phase of clinical trial has different experimental purposes, and the third phase of clinical research has the largest number of people and is the core.

NDA(New Drug Application) is the abbreviation of new drug application, which refers to the process of applying for registration and listing of new drugs after they have passed clinical research. The occurrence of innovative drugs must go through five links, namely, the preparation of chemical substances, preclinical research, clinical research, application for registration on the market, and new drug testing. After the clinical research, before the drug goes on the market, there is the last step, that is, preparing raw materials in advance, applying for registration and applying for listing (NDA declaration). Through the NDA declaration, drugs can only be put on the market after being approved.

Most importantly, because of new drugs (innovative drugs), there are two administrative approval systems that must be completed. Not only the listing of new drugs, but also the listing license of generic drugs, but the whole declaration process of generic drugs is much simpler.

ANDA is the abbreviation of new drug application, that is, generic NDA declaration. Generic drugs are replicas of innovative drugs, and generic drugs also need NDA declaration. However, generic drugs do not need to carry out clinical research, only need to show that their quality and efficacy are consistent with patented drugs. Therefore, their NDA declaration is much simpler, that is, the abbreviation of ANDA is concise and to the point.

The above is a detailed introduction to the FDA's new drug declaration procedures. In short, the declaration of IND is to declare to the government to carry out clinical research; NDA declaration is to declare the registration and listing of drugs to the government; ANDA declaration refers to the application for registration and listing of generic drugs. Related abbreviations are often used in practice, such as IND drugs, that is, drugs in clinical research; The total number of NDA, that is, the total number of drugs that have been declared for marketing, and mastering the meaning of related abbreviations is conducive to better communication with the same industry.