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| 我国已上市治疗用生物制品问题分析及监管建议 |
| Analysis of the problems of biological products for therapeutic use in China and recommendations for regulatory |
| 投稿时间：2019-08-01 修订日期：2019-08-10 |
| DOI： |
| 中文关键词: 生物制品 监管建议 现存问题 |
| 英文关键词: biological products regulatory advice existing problems |
| 基金项目: |
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| 中文摘要: |
| 治疗用生物制品产业发展迅速，在一定程度上满足了我国公众临床用药的需求，但仍与国际先进水平存在较大差距。本文旨在通过对我国已上市治疗用生物制品现状及存在问题进行分析，并在此基础上从鼓励创新、系统构建注册法规等多个角度提出完善监管的建议。 |
| 英文摘要: |
| The therapeutic biological products industry has developed rapidly, to a certain extent, which meets the needs of public clinical medicines in China. But compared with the international advanced level, there are still some shortages. The purpose of this paper is to analyze the status and existing problems of the listed therapeutic biological products in China. On this basis, propose suggestions for regulatory from various angles such as encouraging innovation and systematically establishing registration regulations. |
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