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| 美国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 |
| The Introduction and Exploration on the Process of ‘Special Protocol Assessment’ for Carcinogenicity Studies and Related Regulations by U.S. FDA |
| 投稿时间：2020-05-20 修订日期：2020-08-24 |
| DOI： |
| 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 studies 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( 2018ZX09201-017) |
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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ECAC内部审评流程等方面予以介绍。 结果及结论：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 study is an important part of drug non-clinical safety evaluation and risk controlling of marketing approval. Before the official launching of carcinogenicity studies, 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) for the design of the rodent carcinogenicity studies due to its long test period, high cost, and the complexity of study design, implementation, and evaluation and interpretation of results. This study introduced and explored the key points of the process of SPA for carcinogenicity studies and related regulations by U.S. FDA in detail, to provide some references for domestic institutions for research and development of drug, preclinical CRO, registration and declaration agencies, and drug evaluation agencies of government. Methods: Combined with the requirements of the guidance for industry: “Special Protocol Assessment” for carcinogenicity studies, and our own work experience, the following aspects including the preparation before submitting the study protocols of carcinogenicity studies to CDER of FDA, the procedures for submission, key points in the content of the submission material for SPA review, the internal assessment process of CDER and ECAC were introduced. Results and Conclusion: Sponsor should understand and be familiar with the submitted and evaluated process of SPA for carcinogenicity studies, and be strictly accordance with requirements of regulations, strengthen communication with regulatory authorities, in order to obtain scientific suggestions for developing long-term carcinogenicity studies successful. |
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