A new chemical entity (NCE) is, according to the
U.S. Food and Drug Administration, a novel, small, chemical molecule
drug
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...
that is undergoing clinical trials or has received a first approval (not a new use) by the FDA in any other application submitted under section 505(b) of the
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
.
A new molecular entity (NME) is a broader term that emcompasses both an NCE or an NBE (New Biological Entity).
Definition
An
active moiety
In organic chemistry, a moiety ( ) is a part of a molecule that is given a name because it is identified as a part of other molecules as well.
Typically, the term is used to describe the larger and characteristic parts of organic molecules, and ...
is 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
noncovalent derivative (such as a
complex,
chelate, or
clathrate) of the molecule, responsible for the
physiological or pharmacological action of the drug substance.
An NCE is a
molecule developed by the innovator company in the early
drug discovery
In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered.
Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by ...
stage, which after undergoing
clinical trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
could translate into a drug that could be a treatment for some disease.
Synthesis
Synthesis or synthesize may refer to:
Science Chemistry and biochemistry
*Chemical synthesis, the execution of chemical reactions to form a more complex molecule from chemical precursors
** Organic synthesis, the chemical synthesis of organ ...
of an NCE is the first step in the process of
drug development. Once the synthesis of the NCE has been completed, companies have two options before them. They can either go for clinical trials on their own or license the NCE to another company. In the latter option, companies can avoid the expensive and lengthy process of clinical trials, as the licensee company would be conducting further clinical trials and subsequently launching the drug. Companies adopting this model of business would be able to generate high margins as they get a huge one-time payment for the NCE as well as entering into a revenue sharing agreement with the licensee company.
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.
See also
*
Molecular/chemical entity
*
Medicinal chemistry
*
Drug development
References
{{reflist
External links
NME's worldwide and in GermanyCDER Drug and Biologic Approval Reports
Medicinal chemistry
Pharmaceutical industry
Life sciences industry