In regulatory affairs, we often hear the terms New Molecular Entity (NME) and New Chemical Entity (NCE) used interchangeably. However, they have distinct meanings, especially in the context of drug approval.
New Chemical Entity (NCE)
An NCE is a drug containing an active moiety that has never been approved by the FDA in any form. It refers to a completely new chemical structure that has not been previously used in any approved drug.
New Molecular Entity (NME)
An NME is a broader term referring to a new active ingredient, which may include:
- A completely new chemical structure (NCE)
- A biologic (large molecule) with a novel mechanism of action
- A prodrug or different salt form of an existing molecule, if it has never been previously approved
Key Difference:
- All NCEs are NMEs, but not all NMEs are NCEs.
- NMEs can include biological products, while NCEs refer strictly to small molecules.
Regulatory Impact:
In the U.S., NCEs receive 5-year market exclusivity under the Hatch-Waxman Act, preventing generic competition.
NMEs, particularly biologics, may receive 12 years of exclusivity under the Biologics Price Competition and Innovation Act (BPCIA).
Understanding these distinctions is crucial for professionals in drug development, regulatory affairs, and market access.
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Resource Person: Pratik Pawar