ISSN: 2044-9038 (Print) 2044-9046 (Electronic)

Clinical Practice

Review Articles Of New Chemical Entities

 A new chemical entity (NCE) is, consistent with the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in the other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. A NCE is mentioned as either a replacement drug product or as a replacement drug substance. A New drug product may be a pharmaceutical product type, for instance, tablet, capsule, solution, cream, etc., which has not previously been registered during a region or Member State.  A New drug substance may be a designated therapeutic moiety, which has not previously been registered during a region or Member State (also mentioned as a replacement molecular entity or new chemical entity). It may be a post, simple ester, or salt of a previously approved drug substance. 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 non-covalent derivative (such as a posh, chelate, or clathrate) of the molecule, liable for the physiological or pharmacological action of the drug substance. Under the Food and Drug Administration Amendments Act of 2007, all new chemical entities must first be reviewed by an advisory committee before the FDA can approve these products.  

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