| 引用本文：陈永法, 卞云云, 伍琳.日本生物类似药注册监管政策绩效评价研究及启示[J].中国卫生政策研究,2016,9(12):50-55 |
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| 日本生物类似药注册监管政策绩效评价研究及启示 |
| 投稿时间：2016-09-09 修订日期：2016-11-27 PDF全文浏览 HTML全文浏览 |
| 陈永法, 卞云云, 伍琳 |
| 中国药科大学国际医药商学院 江苏南京 211198 |
| 摘要:目的：为完善我国生物类似药的注册监管提供参考。方法：以日本生物类似药研发注册审评政策为研究对象，分析其注册审评流程及核心特征，并探讨政策实施效果。结果与结论：日本注册监管政策有助于提高生物类似药的可获得性与可支付性，同时促进了生物医药产业的健康发展。启示：我国可以引入适度简化原则，减免部分研发程序和申报资料要求，促进生物类似药的研发上市；沿用新药审评程序，确保生物类似药研发注册的稳定性。 |
| 关键词:生物类似药 注册监管 绩效评价 |
| 基金项目:2015年度国家社会科学基金重大项目（15ZDB167） |
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| Performance of registration regulation policies on biosimilars in Japan and its enlightenment |
| CHEN Yong-fa, BIAN Yun-yun, WU Lin |
| School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing Jiangsu 211198, China |
| Abstract:Objective:This paper intends to provide reference for consummation of biosimilar registration policies in China. Methods:This paper evaluates the performance of Japanese registration regulation policies on biosimilars by analyzing the procedure and reviewing the features of biosimilars. Results and Conclusions:According to the findings of the present investigation, the availability and affordability of biosimilars have been improved, and the biomedicine industry has achieved great development. On the other hand, it's recommended that the guideline for the development and evaluation of biosimilars should be amended on the principle of appropriate simplification, which means to simplify the research and development procedure and exempt partial application dossier. Besides, the registration procedures should be adopted continuously to ensure the stability of biosimilars' R&D and registration. |
| Key words:Biosimilar Registration regulation Performance evaluation |
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