A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products.
New Chemical Entity (NCE) in the US
New chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application. Active moiety includes a molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.
A New Chemical Entities (NCE) is granted exclusivity by the FDA. This exclusivity provides the license holder of an approved new drug application limited protection from new competition in the marketplace for the innovation represented by its approved drug product.
New Chemical Entity (NCE) in the EU
A NCE is referred to as either a new drug product or as a new drug substance. A New drug product is a pharmaceutical product type, for example, tablet, capsule, solution, cream, etc., which has not previously been registered in a region or Member State, and which contains a drug ingredient generally, but not necessarily, in association with excipients. A New drug substance is a designated therapeutic moiety, which has not previously been registered in a region or Member State (also referred to as a new molecular entity or new chemical entity). It may be a complex, simple ester, or salt of a previously approved drug substance