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The Pharma Marketing Glossary
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New Molecular Entity (NME)

Similar or Alternative Terms Meaning the Same Thing n/a
Related Term(s) New Chemical Entity (NCE)

Definitions

A New Molecular Entity (NME) or New Chemical Entity (NCE) is a drug or chemical that is without precedent among regulated and approved drug products. The NME designation indicates that a drug in development is not a version or derivative of an existing and previously investigated, trialed and approved substance. Being labeled as entirely 'new' or first-in-class molecule dictates that certain types of clinical trials must be run, and that particular attention must be paid to proving a drugs safety.


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