文章摘要
黄丽,张素才,戴学栋,孙云霞,孙涛,姚大林.FDA关于致癌性试验“特别方案评估”的流程和相关法规的介绍与探讨[J].中国药事,2020,34(9):1063-1069
FDA关于致癌性试验“特别方案评估”的流程和相关法规的介绍与探讨
Introduction and Exploration on the Process and the Related Regulations of "Special Protocol Assessment" for Carcinogenicity Test by FDA
  
DOI：10.16153/j.1002-7777.2020.09.010
中文关键词: 致癌性试验  致癌性评估执行委员会  特别方案评估
英文关键词: carcinogenicity test  ECAC  Special Protocol Assessment
基金项目:国家“重大新药创制”科技重大专项资助项目(编号 2018ZX09201-017)
作者单位
黄丽 北京昭衍新药研究中心股份有限公司,生物制品安全性评价北京市重点实验室,北京 100176 
张素才 北京昭衍新药研究中心股份有限公司,生物制品安全性评价北京市重点实验室,北京 100176 
戴学栋 国家药品监督管理局药品审评中心,北京 100022 
孙云霞 北京昭衍新药研究中心股份有限公司,生物制品安全性评价北京市重点实验室,北京 100176 
孙涛 国家药品监督管理局药品审评中心,北京 100022 
姚大林 北京昭衍新药研究中心股份有限公司,生物制品安全性评价北京市重点实验室,北京 100176 
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中文摘要:
      目的：致癌性试验是药物非临床安全性评价和上市风险控制的重要组成部分，由于其试验周期长、费用高，且试验设计、实施以及结果评估和解释十分复杂，FDA要求申办方在致癌性试验正式开展前，预先向药品审评中心(CDER)提交“特别方案评估”(Special Protocol Assessment，SPA)的申请文件，针对拟开展的啮齿动物致癌性试验设计，征求FDA的审评意见。本文将详细介绍并探讨美国 FDA关于致癌性试验SPA的流程及相关法规的要点，以期为国内药物研发机构、临床前合同研究组织 (Contract Research Organization，CRO)、注册申报机构以及监管机构提供参考。方法：结合FDA致癌性试验“特别方案评估”指导原则的要求和相关工作经验，从致癌性试验方案提交FDA审评部门前的准备、提交程序、SPA审评文件材料内容的关注要点，以及FDA相关审评部门和致癌性评估执行委员会 (ECAC)内部审评流程等方面予以介绍。结果与结论：申办方应了解并熟悉致癌性试验SPA文件提交和评估的过程，并严格按照法规要求，加强与监管部门的沟通交流，从而获取科学性意见和建议，为顺利开展长期致癌性试验提供帮助。
英文摘要:
      Objective: Carcinogenicity test is an important part of drugs' non-clinical safety evaluation and risk controlling of marketing approval. Before the official launching of carcinogenicity test, the sponsor is required to submit the application documents of "Special Protocol Assessment" (SPA) to Center for Drug Evaluation and Research (CDER) in advance to obtain comments from FDA's Executive Carcinogenicity Assessment Committee (ECAC) on the design of the rodent carcinogenicity test to be conducted due to its long test period, high cost, and the complexity of test design, implementation, evaluation of results and interpretation. This study introduced and explored the key points of the process of SPA for carcinogenicity test and related regulations by FDA in details so as to provide some references for domestic institutions for research and development of drugs, preclinical CRO, registration and declaration agencies, and drug evaluation agencies of government. Methods: Combined with the requirements of the guidance of “Special Protocol Assessment” for carcinogenicity test and our own work experience, the aspects including the preparation before submitting the study protocols of carcinogenicity test to CDER of FDA, the procedures for submission, key points in the contents of the submission material for SPA reviews, and the internal assessment process of CDER and ECAC were introduced. Results and Conclusion: Sponsors should understand and be familiar with process of submitting and evaluating the document of SPA for carcinogenicity test, strictly follow the requirements of regulations, and strengthen communication with regulatory authorities in order to obtain scientific suggestions for successfully conducting long-term carcinogenicity test.
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