文章摘要
赵晓宇,苏岭,杨建红,王刚,耿洁,宋晓东,鲁薪安,张象麟,高凯.药品监管科学研究之基因和细胞治疗产品Ⅱ:我国监管体系的完善建议[J].中国药事,2021,35(5):516-522
药品监管科学研究之基因和细胞治疗产品Ⅱ:我国监管体系的完善建议
Scientific Research II on the Inspection of Gene and Cell Therapy Products: Suggestions on Improving the Regulatory System in China
  
DOI：10.16153/j.1002-7777.2021.05.004
中文关键词: 基因治疗产品  细胞治疗产品  监管政策
英文关键词: gene therapy products  cell therapy products  regulatory policies
基金项目:
作者单位
赵晓宇 沈阳药科大学亦弘商学院,北京 100055 
苏岭 沈阳药科大学亦弘商学院,北京 100055 ；礼来亚洲基金,上海 200021 
杨建红 沈阳药科大学亦弘商学院,北京 100055 
王刚 沈阳药科大学亦弘商学院,北京 100055 ；上海君实生物医药科技股份有限公司,上海 201203 
耿洁 北京汉氏联合生物技术股份有限公司,北京 100176 
宋晓东 上海优替济生生物医药有限公司,上海 201103 
鲁薪安 沈阳药科大学亦弘商学院,北京 100055 ；北京艺妙神州医药科技有限公司,北京 100195 
张象麟 沈阳药科大学亦弘商学院,北京 100055 
高凯 沈阳药科大学亦弘商学院,北京 100055 ；上海大学生命科学学院,上海 200444 
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中文摘要:
      目的：为完善我国基因和细胞治疗产品监管体系提供参考。方法：对美国、欧盟和日本等监管机构的基因和细胞治疗产品监管体系进行对比研究，结合对我国相关行业开展的问卷调研结果进行综合分析。结果与结论：从药品生命周期管理的角度，提出完善我国基因和细胞治疗产品监管体系的建议， 包括我国基因和细胞治疗产品监管体系完善的原则与思路、基因和细胞治疗产品不同生命周期的个性化监管要求、细胞治疗产品双轨制的构建与完善建议，以及提高基因和细胞治疗产品可及性的措施。
英文摘要:
      Objective: To provide references for improving the regulatory system of China's gene and cell therapy products. Methods: A comparative study on the regulatory systems of gene and cell therapy products in the United States, the European Union and Japan was carried out, combined with the results of questionnaire surveys conducted in China by the relevant industries. Results and Conclusion: From the perspective of drug life cycle management, suggestions for improving the regulatory system of China's gene and cell therapy products were proposed, which included suggestions about the principles and ideas for improving the regulatory system of gene and cell therapy products in China, the personalized regulatory requirements for gene and cell therapy products in different life cycles, the construction and improvement of the dual-track system of celltherapy products, as well as the measures to improve the availability of gene and cell therapy products.
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