What is the Difference Between NCE and NME?
🆚 Go to Comparative Table 🆚The main difference between a New Chemical Entity (NCE) and a New Molecular Entity (NME) lies in the presence of an active moiety.
- NCE (New Chemical Entity): An NCE is a drug that contains no active moiety that has been approved by the FDA in any other application submitted under 505(b) of the Act. In other words, an NCE is a novel, small chemical molecule drug that is undergoing clinical trials or has received a first approval.
- NME (New Molecular Entity): An NME is an active ingredient that contains no active moiety that has been previously approved by the Agency in an application submitted under section 505 of the Act or has been previously marketed as a drug in the United States. The FDA defines an NME as a new drug containing an active moiety that has not been approved previously.
In summary, an NCE has no active moiety that has ever been approved, while an NME has an active moiety that has not been approved by the FDA previously. The classification of these entities helps in identifying how the drug behaves and its relation to other ingredients, providing a record of the clinical data.
Comparative Table: NCE vs NME
The main difference between a New Chemical Entity (NCE) and a New Molecular Entity (NME) lies in whether the active ingredient has been previously approved in any form. Here is a table comparing the two:
| Feature | NCE (New Chemical Entity) | NME (New Molecular Entity) |
|---|---|---|
| Definition | A drug that contains no active moiety that has ever been approved by the FDA. | An active ingredient that contains no active moiety that has been previously approved by the FDA. |
| Approval | NCEs are approved under section 505(b) of the Federal Food, Drug and Cosmetic Act. | NMEs are approved under section 505 of the Act. |
| Active Moiety | No active moiety has ever been approved. | The active moiety has not been approved by the FDA previously. |
In summary, NCEs are completely new molecules, while NMEs can include new combinations of previously approved molecules.