| 引用本文:钟丽丹.中成药上市后再评价的现状、挑战与展望[J].世界中医药,2017,(06):. |
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| 中成药上市后再评价的现状、挑战与展望 |
| Current Situation, Challenge and Future Development of Post Marketing Evaluation on Proprietary Chinese Medicines |
| 投稿时间：2017-05-10 |
| DOI：10.3969/j.issn.1673-7202.2017.06.003 |
| 中文关键词: 中成药 上市后再评价 注册制度 |
| English Keywords:Proprietary Chinese Medicines Post marketing evaluation Registration regulations |
| 基金项目:香港浸会大学中医研究项目（编号：FRG1/16-17/042）——建立良好的中医临床方案报告规范 |
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| 中文摘要: |
| 本文检索近十年中成药上市后进行的临床研究，尤其是在SCI杂志上发表的高质量临床研究，回顾目前注册中成药中进行上市后再评价现状及与国际接轨的情况。列出目前中成药进入国际市场存在的问题，并以FDA、加拿大及欧盟对于植物药及草药的注册要求来详细陈述，指出中成药上市后再评价的必要性及未来的发展趋势。 |
| English Summary: |
| This study has reviewed the post market clinical trials of Proprietary Chinese Medicine, especially those which have published high quality SCI papers to assess the current situation and challenges faced in this area. At the same time, we also listed the registration differences between Food and Drug Administration （FDA）, European Medicine Agency and Health Canada. This study further analyzed the necessity and trend of post marketing evaluation of Proprietary Chinese Medicines. |
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