| 李培.国内药品注册沟通交流制度介绍与思考[J].中国药事,2021,35(12):1340-1346 |
| 国内药品注册沟通交流制度介绍与思考 |
| Introduction and Consideration of Communication System for Drug Registration in China |
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| DOI：10.16153/j.1002-7777.2021.12.003 |
| 中文关键词: 沟通交流制度 药品注册 政策法规 创新药 改革 |
| 英文关键词: communication system drug registration relevant laws and regulations innovative drug reform |
| 基金项目: |
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| 中文摘要: |
| 目的： 为深入推进药品审评审批制度改革，加强药品技术审评沟通交流，为申请人合理利用沟通交流方式提出思考与建议。方法： 梳理我国申请人与药审中心沟通交流制度建立和完善过程，介绍沟通交流的演变历史、现阶段的政策法规和技术要求等，分析近年来沟通交流情况和存在的问题。结果与结论：随着药品审评改革的不断深入，注册沟通交流制度不断完善，研发者和监管机构应共同努力，持续推进制度建设，充分利用沟通交流渠道，促进创新药的研究和开发。 |
| 英文摘要: |
| Objective: To further promote the reform of the drug review and approval system, strengthen the communication of drug technical review, and put forward suggestions for applicants on the rational use of communication methods. Methods: The process of establishing and improving the communication mechanism between registration applicants and review institutions in China was summarized, the evolution history of communication, current policies, regulations and technical requirements, etc. were introduced, the communication situation and existing problems in recent years were analyzed. Results and Conclusion: With the continuous deepening of drug review reform, the registration communication system has been continuously improved. Developers and regulators should work together to promote system construction and make full use of communication channels, to promote the research and development of innovative drugs. |
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