New chemical entity

{
  "id": "MLC-T-CHM-007928",
  "term": "New chemical entity",
  "field": "Chemistry",
  "definition": "A drug that contains an active moiety not previously approved by a particular regulatory authority for marketing in any other drug product. The active moiety is the molecule or ion responsible for the drug's pharmacological action, excluding appended portions of the molecule that cause it to be an ester, salt, or other noncovalent derivative. Approval of a new chemical entity (NCE) is distinct from the approval of new formulations or combinations of previously approved drugs.",
  "subject": "Chemistry and Human Health",
  "see_also": [
    "new molecular entity"
  ],
  "references": [
    "PAC, 2013, 85, 1725. 'Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)' on page 1743 (https://doi.org/10.1351/PAC-REC-12-11-23)"
  ],
  "url": "https://mlchart.com/terminology/chemistry/new-chemical-entity/"
}