A new chemical entity (NCE) is a term for a drug that contains a previously undiscovered active pharmaceutical ingredient (API). Synonyms for NCE include new molecular entity (NME), novel drug, innovative drug, and new active substance (NAS). These terms are often used interchangeably to refer to new drugs or compounds that have not been previously approved by regulatory agencies for use in humans. Developing a NCE involves a complex process of drug discovery, preclinical and clinical testing, and regulatory approval. The term NCE highlights the novelty and potential for therapeutic benefit of a newly developed drug, and is an important concept in the field of drug development.