| 摘要: |
| 目的 为拟在美国注册申报化学仿制药的中国企业提供立项指导和帮助，从目标产品的初步获得、产品具体信息的调研分析评估，到最终策略的制定，进行系统的介绍。方法 主要采用例证法。结果 获得美国仿制药立项信息收集及评估的途径和方法，形成并明确开发注册策略制定的思路和要素。结论 美国的药品信息比较透明公开，从公共途径基本可以获得产品开发所需要的相关信息。立项评估并不能做到百分百正确无误，企业可以设立自己的立项标准，只要在企业可接受范围内即可进行。 |
| 关键词: FDA 化学仿制药 立项调研 评估 策略 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.01.023 |
| 分类号:R951 |
| 基金项目: |
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| Project Feasibility Research and Evaluation for Generic Drug |
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LI Yanyan, CHEN Shuqing
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Zhejiang University, Hangzhou 310058, China
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| Abstract: |
| OBJECTIVE To provide guidance and assistance for Chinese enterprise planning to apply for ANDA approval from the FDA. Introduce how to get the target product and how to investigate and evaluate, then finally make the strategy. METHODS The methodology mainly used was exemplification. RESULTS Obtained the way and methods of collection and evaluation of drug information in the U.S., clarified the factors of generating development and registration strategies. CONCLUSION Drug information in the U.S. is transparent and public relatively, and available from public sources. The project evaluation can't be absolutely correct, so enterprises can set up their acceptable standards according to their own requirements. |
| Key words: FDA generic drug project research evaluation strategy |
