中国、美国和欧盟的细胞治疗监管政策浅析
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摘要
2017年,2款嵌合抗原受体T细胞免疫疗法(CAR-T)类细胞免疫治疗产品获得美国FDA批准上市,引起了社会各界对细胞免疫治疗领域的关注。本文着重介绍了我国、美国和欧盟对于细胞治疗技术及产品的监管政策历史、现状及其异同,并对我国细胞治疗产品监管政策的制定提出了建议。
In 2017,two CAR-T cell immune therapy products were approved by FDA,which attracted whole society's attention on cellular immunotherapy. This article mainly introduced the history and current situation of the regulatory policies on cell therapy technology and products in China,USA and EU,as well as their similarities and differences,and made some recommendations on regulatory policies for cell therapy products in China.
In 2017,two CAR-T cell immune therapy products were approved by FDA,which attracted whole society's attention on cellular immunotherapy. This article mainly introduced the history and current situation of the regulatory policies on cell therapy technology and products in China,USA and EU,as well as their similarities and differences,and made some recommendations on regulatory policies for cell therapy products in China.
引文
[1] U. S. Food and Drug Administration. Bioresearch Monitoring Discipline Review Memo,August 1,2017-KYMRIAH[EB/OL].[2018-03-01]. https://www. fda. gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/ucm573706. htm.
[2] U. S. Food and Drug Administration. Amended Bioresearch Monitoring Discipline Review Memo,October 12,2017-YESCARTA[EB/OL].[2018-02-20]. https://www. fda. gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/ucm581222. htm.
[3]卫生部办公厅关于公布首批允许临床应用的第三类医疗技术目录的通知[EB/OL].[2009-05-01]. http://www. moh.gov. cn/yzygj/s3589/201308/19a61b03ddcc40309a66f630c775c892.shtml.
[4]国家卫生计生委关于取消第三类医疗技术临床应用准入审批有关工作的通知[EB/OL].[2015-07-02]. http://www.nhfpc. gov. cn/yzygj/s3585/201507/c529dd6bb8084e09883ae417256b3c49. shtml.
[5]细胞治疗产品研究与评价技术指导原则(试行)[EB/OL].[2017-12-22]. http://samr. cfda. gov. cn/WS01/CL0087/220082. html.
[6]吴曙霞,杨淑娇,吴祖泽.美国、欧盟、日本细胞治疗监管政策研究[J].中国医药生物技术,2016,11(6):491-496.
[7]田佳鑫.美国FDA对再生医学产品的监管及启示[J].生物技术通讯,2017,28(5):685-688.
[8]韩倩倩,王春仁.基因治疗产品、细胞治疗产品和组织工程产品在欧盟的监管[J].组织工程与重建外科,2014,10(5):244-246.
[9] Committee for Advanced Therapies(CAT)[EB/OL].[2018-06-27]. http://www. ema. europa. eu/ema/index. jsp? curl=pages/about_us/general/general_content_000266. jsp&mid=WC0b01ac05800292a4.
[10] NAGPAL A,JUTTNER C,HAMILTONBRUCE MA,et al. Stem cell therapy clinical research:a regulatory conundrum for academia[J]. Adv Drug Deliv Rev,2017,122:105-114.
[11] COSSU G,BIRCHALL M,BROWN T,et al. Lancet commission:stem cells and regenerative medicine[J]. Lancet,2018,391:883-910.
[2] U. S. Food and Drug Administration. Amended Bioresearch Monitoring Discipline Review Memo,October 12,2017-YESCARTA[EB/OL].[2018-02-20]. https://www. fda. gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/ucm581222. htm.
[3]卫生部办公厅关于公布首批允许临床应用的第三类医疗技术目录的通知[EB/OL].[2009-05-01]. http://www. moh.gov. cn/yzygj/s3589/201308/19a61b03ddcc40309a66f630c775c892.shtml.
[4]国家卫生计生委关于取消第三类医疗技术临床应用准入审批有关工作的通知[EB/OL].[2015-07-02]. http://www.nhfpc. gov. cn/yzygj/s3585/201507/c529dd6bb8084e09883ae417256b3c49. shtml.
[5]细胞治疗产品研究与评价技术指导原则(试行)[EB/OL].[2017-12-22]. http://samr. cfda. gov. cn/WS01/CL0087/220082. html.
[6]吴曙霞,杨淑娇,吴祖泽.美国、欧盟、日本细胞治疗监管政策研究[J].中国医药生物技术,2016,11(6):491-496.
[7]田佳鑫.美国FDA对再生医学产品的监管及启示[J].生物技术通讯,2017,28(5):685-688.
[8]韩倩倩,王春仁.基因治疗产品、细胞治疗产品和组织工程产品在欧盟的监管[J].组织工程与重建外科,2014,10(5):244-246.
[9] Committee for Advanced Therapies(CAT)[EB/OL].[2018-06-27]. http://www. ema. europa. eu/ema/index. jsp? curl=pages/about_us/general/general_content_000266. jsp&mid=WC0b01ac05800292a4.
[10] NAGPAL A,JUTTNER C,HAMILTONBRUCE MA,et al. Stem cell therapy clinical research:a regulatory conundrum for academia[J]. Adv Drug Deliv Rev,2017,122:105-114.
[11] COSSU G,BIRCHALL M,BROWN T,et al. Lancet commission:stem cells and regenerative medicine[J]. Lancet,2018,391:883-910.