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疑夕2014

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专业: 药物化学

[求助] 中国的“首仿药”到底指什么？已有10人参与

美国将药品分为专利药（品牌药）、仿制药（通用名药），仿制药实行一报一批，批准第一个仿制药后的180天内不批其他的仿制药，这个药就是首仿，那么在中国首仿到底指什么？

问题1：首仿药的概念出自哪个官方文件？

问题2：首仿药是新药还是仿制药？（美国明确为仿制药）

问题3：首仿药的临床研究与普通仿制药有误差别？（美国无差别）

问题4：首仿药的保护期是多久？（美国规定为180天）

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1楼2014-01-09 17:18:00

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lunar3809

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疑夕2014(星海慧儿代发): 金币+5, 很有帮助，多谢回帖交流 2014-02-10 11:50:20
凌宇雷池: 回帖置顶 2014-02-11 16:09:28

引用回帖:

23楼: Originally posted by 疑夕2014 at 2014-01-10 11:50:09
你没选应助，我评不了分，30个金币全给你好了。...

不用了！帮人的过程也是学习深化自己的过程！
这是Food, Drug, and Cosmetic Law 的关于新药的定义！
(p) The term “new drug” means—
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a “new drug” if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
ICH Q3a也有新药概念！感兴趣你可以自己看一下！
NDA不仅针对新分子实体！同时！新化学成分，原批准药品新配方，新适应症，新剂型，给药途径，规格。原药品的新盐基酯基！都安找FDA新药审批的！
也不是按照上市否分类的！
研究分类最好研究各国注册相关的指导原则！而不是从实例往前推是什么类型！