Difference Between NCE and NME

The key difference between NCE and NME is that NCE has no active moiety that has ever been approved by the FDA (Food and Drug Administration) whereas NME has an active moiety that has not been approved by the FDA previously.

The terms NCE and NME are used to categorize drugs according to the presence or absence of active moieties, which are the portions of drugs which can affect the activity of the drug. Generally, a drug with an active moiety is therapeutically more beneficial. FDA states that a drug that contains no active moiety as previously approved by FDA is a new molecular entity or NME and a drug that contains an active moiety that has been approved by FDA is a new chemical entity or NCE.

1. Overview and Key Difference
2. What is NCE
3. What is NME
4. Side by Side Comparison – NCE vs NME in Tabular Form
5. Summary

What is NCE?

NCE stands for New Chemical Entity. According to the FDA, NCE is a drug that contains no active moiety that has ever been approved by the FDA. That means; the drugs in this class does not have a single approved moiety that is active. This specific approval is given regarding the section 505(b) of the Federal Food, Drug and Cosmetic Act. Typically, the products that come under the NCE category receive a five-year market exclusivity after getting the approval. Furthermore, during this five-year time period, the FDA does not accept any applications for generic versions of the product submitted under the 505(b) Act.

Moreover, an active moiety usually includes a molecule or an ion. However, it excludes parts of the molecule that causes it to become an ester, salt or some other derivative of these two forms (for example, chelate, complex, etc.) that is responsible for the physiological activity of the product. Furthermore, the new chemical entity can be a tablet, capsule, solution, cream, etc.

What is NME?

NME stands for New Molecular Entity. The term describes any drug that contains an active moiety which has never been approved by the FDA. Therefore, the products that come under this category have at least one unapproved (previously) active moiety.

Moreover, the products under NME receives three years for market data exclusivity. This time period is given if this active moiety is a moiety that has been approved by the FDA previously and now is subjected to new clinical investigations. Furthermore, if a company releases the new clinical investigation data for a certain product that has an active moiety, then this product comes under the category of NME.

What is the Difference Between NCE and NME?

The terms NCE and NME are used to categorize drugs according to the presence or absence of active moieties. The key difference between NCE and NME is that NCE has no active moiety that has ever been approved by the FDA, whereas NME has an active moiety that has not been approved by the FDA previously.

Moreover, there is another difference between NCE and NME in the time period given for market data exclusivity; for NCE, the time period for market data exclusivity is five years, and for NME, it is three years. Furthermore, during this five-year time period given for NCE, the FDA does not accept any applications for generic versions of the product submitted under the 505(b) Act. For NME, this time period is given if this active moiety is a moiety that has been approved by the FDA previously and now is subjected to new clinical investigations.

Summary – NCE vs NME

Reference:

1. “New Chemical Entity (NCE).” Voisin Consulting Life Sciences, 22 Mar. 2018, Available here.

Image Courtesy:

1. “931638” (CC0) via Pxhere
2. “Drug Evaluation Process” By Kernsters – Graph created based on information provided in Scientific American article, “Faster Evaluation of Vital Drugs” (CC BY-SA 3.0) via Commons Wikimedia