下面是小编为大家整理的【中英文对照版】兽药管理条例(2020修订),供大家参考。
1 兽药管理条例(2020 修订) Regulation on Veterinary Drug Administration （2020 Revision）
【中英文对照版】
发布部门：国务院
发文字号：中华人民共和国国务院令第726 号 发布日期：2020.03.27 实施日期：2020.03.27 效力级别：行政法规 法规类别：兽医兽药 Issuing Authority ：
State Council Document Number ：Order No. 726 of the State Council of the People"s Republic of China
Date Issued ：03-27-2020
Effective Date ：03-27-2020
Level of Authority ：
Administrative Regulations Area of Law ：
Veterinarian and Veterinary Drugs
Regulation on Veterinary Drug Administration 兽药管理条例
(Promulgated by the Order No. 404 of the State Council of the People"s Republic of China on April 9, 2004; revised for the first time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on July 29, 2014; and revised for the second time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016; and revised for the third time in accordance with the Decision of the State Council to Amend and Repeal Certain Administrative Regulations (2020) on March 27, 2020) （2004 年 4 月 9 日中华人民共和国国务院令第 404 号公布 根据 2014 年 7 月 29 日《国务院关于修改部分行政法规的决定》第一次修订 根据 2016 年 2 月 6日《国务院关于修改部分行政法规的决定》第二次修订 根据2020 年 3 月 27 日《国务院关于修改和废止部分行政法规的决定》第三次修订）
Chapter I General Provisions
第一章 总则
Article 1 The present Regulation is formulated in order to strengthen veterinary drug administration, guarantee veterinary drug quality, prevent and control animal diseases, promote the development of breeding industry, and maintain human health.
第一条 为了加强兽药管理，保证兽药质量，防治动物疾病，促进养殖业的发展，维护人
2 体健康，制定本条例。
Article 2 The present Regulation shall apply to the research, production, operation, import, export, use or supervision of veterinary drugs inside the territory of the People"s Republic of China.
第二条 在中华人民共和国境内从事兽药的研制、生产、经营、进出口、使用和监督管理，应当遵守本条例。
Article 3 The responsibility to supervise veterinary drugs nationwide shall remain with the veterinary administration under the State Council.
第三条 国务院兽医行政管理部门负责全国的兽药监督管理工作。
The responsibility to supervise veterinary drugs within a certain jurisdiction shall remain with the veterinary administration under the local people"s government at the county level or above. 县级以上地方人民政府兽医行政管理部门负责本行政区域内的兽药监督管理工作。
Article 4 The state applies a system of administering veterinary drugs by classifying them into prescription veterinary drugs and non-prescription ones. The measures for classifying prescription veterinary drugs and non-prescription ones as well as the specific implementing procedures shall be formulated by the veterinary administration under the State Council.
第四条 国家实行兽用处方药和非处方药分类管理制度。兽用处方药和非处方药分类管理的办法和具体实施步骤，由国务院兽医行政管理部门规定。
Article 5 The state applies a veterinary drug reserve system.
第五条 国家实行兽药储备制度。
In case of any major animal epidemic situation, disaster situation or any other unexpected incident, the veterinary administration under the State Council may urgently put the state-reserved veterinary drugs into use. If necessary, it may also put veterinary drugs other than the state-reserve ones into use. 发生重大动物疫情、灾情或者其他突发事件时，国务院兽医行政管理部门可以紧急调用国家储备的兽药；必要时，也可以调用国家储备以外的兽药。
Chapter II Research of New Veterinary Drugs
第二章 新兽药研制
3
Article 6 The state encourages the research of new veterinary drugs, and protects the lawful rights and interests of the researchers in accordance with the law.
第六条 国家鼓励研制新兽药，依法保护研制者的合法权益。
Article 7 Whoever researches a new veterinary drug shall have the suitable site, devices, equipment, professionals, as well as safety management rules and measures.
第七条 研制新兽药，应当具有与研制相适应的场所、仪器设备、专业技术人员、安全管理规范和措施。
Whoever develops a new veterinary drug shall subject it to safety evaluation. An entity engaged in the safety evaluation of veterinary drugs shall abide by the quality control rules on the non-clinical research of veterinary drugs and the quality control rules on the clinical trial of veterinary drugs, as developed by the veterinary administrative department of the State Council. 研制新兽药，应当进行安全性评价。从事兽药安全性评价的单位应当遵守国务院兽医行政管理部门制定的兽药非临床研究质量管理规范和兽药临床试验质量管理规范。
The veterinary administrative departments of the people"s governments at or above the provincial level shall oversee and inspect whether entities engaged in the safety evaluation of veterinary drugs have abided by the quality control rules on the non-clinical research of veterinary drugs and the quality control rules on the clinical trial of veterinary drugs, and shall disclose the inspection results. 省级以上人民政府兽医行政管理部门应当对兽药安全性评价单位是否符合兽药非临床研究质量管理规范和兽药临床试验质量管理规范的要求进行监督检查，并公布监督检查结果。
Article 8 The developer of a new veterinary drug shall, before the clinical test of the drug, report to the veterinary administrative department of the people"s government of the province, autonomous region or municipality directly under the Central Government at the place where the clinical test is conducted for recordation, with the laboratory safety evaluation report and other preclinical study materials of such a new veterinary drug attached.
第八条 研制新兽药，应当在临床试验前向临床试验场所所在地省、自治区、直辖市人民政府兽医行政管理部门备案，并附具该新兽药实验室阶段安全性评价报告及其他临床前研究资料。
If the new veterinary drug in research is a biological product, the researcher shall, prior to the clinical trial, file an application to the veterinary administration under the State Council. And the veterinary administration under the State Council shall, within 60 working days as of receipt of the application, notify the applicant in writing of the result of the examination. 研制的新兽药属于生物制品的，应当在临床试验前向国务院兽医行政管理部门提出申请，国务院兽医行政管理部门应当自收到申请之日起 60 个工作日内将审查结果书面通知申请人。
4 Whoever needs to use the first category of pathogenic microorganism when researching a new veterinary drug shall, in addition, meet the conditions provided for by the veterinary administration under the State Council, and shall report to the veterinary administration under the State Council prior to the laboratory stage for approval. 研制新兽药需要使用一类病原微生物的，还应当具备国务院兽医行政管理部门规定的条件，并在实验室阶段前报国务院兽医行政管理部门批准。
Article 9 After the clinical trial is completed, the new veterinary drug researcher shall, when filing an application to the veterinary administration under the State Council for registration of the new veterinary drug, submit a sample of this new veterinary drug and the following information:
第九条 临床试验完成后，新兽药研制者向国务院兽医行政管理部门提出新兽药注册申请时，应当提交该新兽药的样品和下列资料：
(1) the name, main components, physical and chemical characteristics; (一)名称、主要成分、理化性质；
(2) the research method, production process, quality standards and testing method; (二)研制方法、生产工艺、质量标准和检测方法；
(3) the result of pharmacological and toxicological trial, the clinical trial report and the stability trial report; and (三)药理和毒理试验结果、临床试验报告和稳定性试验报告；
(4) the environmental impact report and the measures for prevention and control of pollution. (四)环境影响报告和污染防治措施。
If the researched new veterinary drug is a biological product, the researcher shall provide the relevant documents and information on culture (virus, worm seed) and cells, etc.. The culture (virus, worm seed) and cells shall be preserved by an institution designated by the veterinary administration under the State Council. 研制的新兽药属于生物制品的，还应当提供菌(毒、虫)种、细胞等有关材料和资料。菌(毒、虫)种、细胞由国务院兽医行政管理部门指定的机构保藏。
When researching a new veterinary drug for edible animals, the researcher shall carry out a trial on veterinary drug remnants in accordance with the provisions of the veterinary administration under the State Council, and shall provide such information as the withdrawal period, the maximum limitation of remnants, the methods of testing remnants and the basis thereof, etc. 研制用于食用动物的新兽药，还应当按照国务院兽医行政管理部门的规定进行兽药残留试验并提供休药期、最高残留限量标准、残留检测方法及其制定依据等资料。
The veterinary administration under the State Council shall, within 10 working days as of receipt of the application, deliver the documents on the new veterinary drug under acceptance to the veterinary drug review and adjudication office it has set up for review and adjudication, and deliver the sample of the new 国务院兽医行政管理部门应当自收到申请之日起 10 个工作日内，将决定受理的新兽药资料送其设立的兽药评审机构进行评审，将新兽药样品送其指定的检
5 veterinary drug to its designated inspection office for re-check and inspection, and shall complete the examination within 60 working days as of receipt of the conclusion of the review and adjudication and the conclusion of the re-check and inspection. If it is examined as qualified, a new veterinary drug registration certificate shall be issued, and the quality standards on this veterinary drug shall be promulgated. Otherwise, the said veterinary administration shall notify the applicant in writing. 验机构复核检验，并自收到评审和复核检验结论之日起 60 个工作日内完成审查。审查合格的，发给新兽药注册证书，并发布该兽药的质量标准；不合格的，应当书面通知申请人。
Article 10 The state protects the undisclosed trial data and other data of the lawfully registered veterinary drug containing new compound, which are submitted by any applicant who has obtained such data by himself.
第十条 国家对依法获得注册的、含有新化合物的兽药的申请人提交的其自己所取得且未披露的试验数据和其他数据实施保护。
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