FDA发布最终版兽药基因毒性检测指南

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FDA发布最终版兽药基因毒性检测指南

May 12, 2015

The U.S. Food and Drug Administration today issued afinal guidance for industry (GFI) on genotoxicity testing: #116, Studiesto Evaluate the Safety of Residues of Veterinary Drugs in Human Food:Genotoxicity Testing.

美国FDA今天发布最终版的基因毒性方面的行业指南#116，评价人用食品中兽药残留安全性研究：基因毒性检测

The guidance recommends a standard battery of teststhat can be used for the evaluation of the genotoxicity of veterinary drugs andis intended to facilitate the mutual acceptance of data necessary to establishacceptable daily intakes (ADIs) for veterinary drug residues in human food bythe relevant regulatory authorities.

指南推荐一成套检测用于评价兽药基因毒性，并旨在促进互相承认的数据用于相关监管机构建立人用食品中兽药残留量的可接受日摄入量

The guidance was developed by the InternationalCooperation on Harmonisation of Technical Requirements for Registration ofVeterinary Medicinal Products (VICH). VICH is an international body thatstrives to harmonize technical requirements for veterinary product registration(approval) in the U.S., European Union, and Japan. VICH seeks scientificallybased technical procedures for developing pharmaceutical products and aims toreduce differences in technical requirements for drug development amongregulatory agencies in different countries.

指南由国际兽药产品注册要求协调合作组织（VICH）开发，VICH是一个致力于协调统一美国，欧盟、日本的兽用产品注册技术要求的国际组织，VICH为药品研发寻求基于科学的技术程序，同时致力于减少不同国家监管机构中药物研发方面的技术要求。

FDA guidance documents represent the agency’s latestthinking on particular topics, policies and regulatory issues. While guidancedocuments are prepared primarily for the benefit of industry, they also areused by FDA staff and other stakeholders to understand the agency’sinterpretation of regulations and policies.

FDA指南代表了该机构在特殊议题，政策和监管方面的最新想法，虽然指南文件最初主要是为行业利益制定，但是他也被FDA人员和其他利益方用于理解FDA机构对法规政策的理解。

Although this guidance has been finalized, you cansubmit comments at any time. To electronically submit comments to the docket,visit www.regulations.gov andtype FDA-2000-D-0598 in the search box. To submit comments to the docket bymail, use the following address. Be sure to include docket numberFDA-2000-D-0598 on each page of your written comments.

尽管该指南已定稿，但是你可以在任何时间提交你的建议评论>>>>>>>>>略

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HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

孙艳红

感谢分享，学习了

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