Comparison of additional regulatory requirements for conducting clinical trials on genetically-modified microorganisms and recombinant DNA in Europe, the United States, and Canada
Comparison of additional regulatory requirements for conducting clinical trials on genetically-modified microorganisms and recombinant DNA in Europe, the United States, and Canada
复制标题
DOI：
10.1177/009286150203600217
复制
发表时间：
2002-04-01
影响因子：
--
通讯作者：
Lee, KC
中科院分区：
文献类型：
--
作者：
Lee, KC
与转基因生物和重组DNA相关的临床试验数量将在未来十年内呈指数级增长。本文介绍并比较了欧洲、美国和加拿大对转基因生物和重组DNA相关临床试验的监管要求。在欧洲，额外的监管要求包括地方和国家转基因生物安全委员会以及基因治疗委员会（如适用）的提交和批准。如果转基因生物是从另一个国家进口的，还需要“进口商”证明。在美国，额外的监管要求包括机构生物安全委员会和重组DNA咨询委员会的审查/批准。对于基因治疗，美国食品和药物管理局需要提供更多信息。在加拿大，需要由机构生物安全委员会（生物危害）和加拿大卫生研究所（由其资助的研究）进行审查。
The number of clinical trials related to genetically-modified organisms and recombinant DNA will increase exponentially in the next decade. This article describes and compares the European, United States, and Canadian regulatory requirements for conducting clinical trials related to genetically-modified organisms and recombinant DNA. In Europe, the additional regulatory requirements include submissions and approvals from the local and national genetically-modified organisms safety committees, and the gene therapy committee (if applicable). If the genetically-modified organism is imported from another country, an "importer" certification is also required. In the United States, the additional regulatory requirements include review/approval by the institutional biosafety committee and the Recombinant DNA Advisory Committee. For gene therapy, additional information is required by the Food and Drug Administration. In Canada, review by the institutional biosafety committee (for biological hazards) and Canadian Institutes of Health Research (for research it funds) is required.