title: "New drug" designations for new therapeutic entities: new active substance, new chemical entity, new biological entity, new molecular entity.
abstract: This Perspective addresses ambiguities in designations of "new drugs" intended as new therapeutic entities (NTEs). Designation of an NTE as a new drug is significant, as it may confer regulatory exclusivity, an important incentive for development of novel compounds. Such designations differ between jurisdictions according to their drug laws and drug regulations. Chemical, biological, and innovative drugs are addressed in turn. The terms new chemical entity (NCE), new molecular entity (NME), new active substance (NAS), and new biological entity (NBE) as applied in worldwide jurisdictions are clarified. Differences between them are explored through case studies showing why new drugs have different periods of exclusivity in different jurisdictions or none at all. Finally, this Perspective recommends that in future, for the purpose of new drug compilations, NME is used for a new chemical drug, NBE for a new biological drug, and the combined designation NTE should refer to either an NME or an NBE.
authors.affiliation: Medicines and Healthcare products Regulatory Agency , 151 Buckingham Palace Road, London, SW1W 9SZ, U.K.
authors.forename: Sarah K
authors.initials: SK
authors.lastname: Branch
authors.forename: Israel
authors.initials: I
authors.lastname: Agranat
mesh_terms: D001688:Biological Products; D002170:Canada; D017277:Drug Approval; D004338:Drug Combinations; D015507:Drugs, Investigational; D005062:European Union; D049673:History, 20th Century; D049674:History, 21st Century; D007880:Legislation, Drug; D010330:Patents as Topic; D009626:Terminology as Topic; D013792:Thalidomide / Q000266:history; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D004338:Drug Combinations; D015507:Drugs, Investigational; D013792:Thalidomide