New chemical entity definition

New chemical entity means a medicinal product containing an active substance which has not been previously included in a medicinal product approved for registration in the Slovak Republic for human use, including new combinations, salts or esters of previously marketed substances.
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New chemical entity means - a chemical or biologically Active Pharmaceutical Ingredient (API) that has not previously been issued with a marketing authorization as an ingredient of any pharmaceutical product in Sierra Leone.
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New chemical entity means any substance that has not been approved for marketing as a drug by a drug regulatory authority of any country including the authorities specified under these rules and is proposed to be developed as a new drug for the first time by establishing its safety and efficacy;
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Examples of New chemical entity in a sentence

  • New chemical entity applications that include pre-clinical and clinical information in support of the efficacy and safety of the formulation/dosage form, indication/s and dosage regimen.

  • Various stages of drug - New chemical entity (NCE), new drug, investigational new drug (IND), new drug applications (NDA), active pharmaceutical ingredient (API), abbreviated new drug application (ANDA), generic drug product.

  • If the cost of these failed drugs is taken into account, the cost of developing a successful new drug (New chemical entity or NCE), has been estimated at about 1.3 billion USD (not including marketing expenses).

  • New chemical entity: A chemically-synthesized Active Pharmaceutical Ingredient (API) that has not previously been registered as an ingredient of any pharmaceutical product in any country.

  • New chemical entity: All compound that has not been presented or described in the past in any national or international publication, and that has not been authorized for its use and/or commercialization in any country of the world.


More Definitions of New chemical entity

New chemical entity means a chemical entity which has or is claimed to have therapeutic activity and is claimed in a composition of matter Patent in the United States or EU.
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New chemical entity means a drug candidate that has a composition of matter or active moiety that is different from previous drug candidate IND applications filed by Licensee for the Field of Use.
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New chemical entity means any substance that has not been approved for marketing as a drug by a drug regulatory authority of any country including the
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New chemical entity means a drug that contains no active moiety that has been approved by the US FDA in any application submitted under Section 505(b) of the US Federal Food, Drug and Cosmetic Act.
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New chemical entity means a drug that contains no active moiety that has been approved by the Food and Drug Administration in any other application submitted under section 505(b) of the act. Thus, FDA interprets the statutory requirement that a drug (new chemical entity) contain “no [previously approved] active ingredient (including any ester or
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New chemical entity means an active ingredient of a sterilant or disinfectant which is not included as an active ingredient in a sterilant or disinfectant product currently entered in the Australian Register of Therapeutic Goods (ARTG), or an excipient of a sterilant or disinfectant which is not included in either the Australian Inventory of Chemical Substances (AICS) or the ARTG.
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New chemical entity means any substance that has not been approved for marketing as a drug by any drug regulatory authority and is proposed to be developed as a new drug for the first time by establishing its safety and efficacy;
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