NCE和NME的区别

wxg0403

   FDA专利里面有NCE（new chemical entity）和NME（new molecular entity）的区别是什么呢？感觉此概念有些模糊，国内一些文献直接将其混为一谈，在Wiki上面有如下一段话A new chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

   A new molecular entity (NME) is different from an NCE   但终究没搞懂NCE与NME的区别，有没有对这两个区别有明确的解释，请各位指教

瓶瓶

NCE和NME最大的区别在于前者(NCE)不含有曾经被FDA批准的合格的或者505(b)段下正在递交或者递交了的Active moiety,后者(NME)是含有从来不曾被FDA或者美国市场批准的Active moiety.
FDA的说明定义这个Active moiety 就是the molecule or ion responsible for the physiological or pharmacological action of the drug substance.
很抱歉我虽然知道他写的是什么但是不知道怎么准确翻译给你,基本上就是生理或者药理上的有效分子或者离子.
这两个定义看上去混乱其实还是有区别的,说得更直接一点,根据这个定义NME除了可以是NCE之外也可以是biological entities.
另外最重要的一点就是NCE批下来之后政府是有五年exclusivity的,NME是没有的.

山顶洞人

瓶瓶 发表于 2020-2-26 08:36
NCE和NME最大的区别在于前者(NCE)不含有曾经被FDA批准的合格的或者505(b)段下正在递交或者递交了的Active m ...

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瓶瓶

欢迎大家拍砖

blueangelhui

看到FDA对于NCE和NME的定义，怎么翻译比较贴切呢？
• New Chemical Entity (NCE): As defined under 21 CFR 314.108(a), a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act.
• New Molecular Entity (NME): 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.

nikki6413

谢谢分享！很专业的分析