Glossary of Clinical Terms

A New Chemical Entity (NCE) is a new compound that has not been approved and introduced anywhere in the world. Technically, NCE is defined as <<a drug which consists of an active moiety that has previously not been approved by any regulatory agencies such as FDA, EMA, etc.>>. 

NCE can be any chemical or biological moiety that possesses a pharmacological activity classifying it as a potential drug for human use.

The NCE-1 is a date that represents the first chance for a generic drug manufacturer to file Abbreviated New Drug Applications (ANDAs) for entry of generics into branded drug marketplaces when the market exclusivity of the patented drug product is nearing completion.