农业部公告第1247号（兽用化学药物安全药理学试验指导原则等）

为加强兽药注册管理,保证兽药安全、有效和质量可控,根据《兽药管理条例》和《兽药注册办法》规定,我部组织制修订了《兽用化学药物安全药理学试验指导原则》等15个兽药试验指导原则,现予发布,并就有关事项公告如下：     

VICH血药法生物等效性指导原则概述

血药法生物等效性试验是开展兽药比对试验工作的重要手段之一。VICH血药法生物等效性指导原则介绍了除多次采血困难的靶动物(如蜂、鱼)的动物血药法生物等效性的实验建议,使基本药代动力学试验、生物等效性试验设计和统计分析原则等在VICH地区得到互认。该指导原则2016年8月开始实施。     

VICH GL43指导原则适用性研究

兽用药品注册技术要求国际协调会(VICH)指导原则转化是补充我国兽药技术指导原则的一种途径。对VICH GL43在我国兽药注册中的适用性进行研究，并与我国发布的相关指导原则技术要点进行比较，分析和讨论一般靶动物安全试验和其他情形靶动物安全性试验在动物选择、研究设计、给药方案、实验参数等方面的考虑和要求，并评估其适用性，为兽药研发和技术评审相关人员提供参考。     

农业部发布《兽用生物制品注册分类及注册资料要求》等公告

农业部于 2 0 0 4年 1 2月 2 2日发布第 442号公告 ,根据《兽药管理条例》和《兽药注册办法》的规定 ,农业部制定了《兽用生物制品注册分类及注册资料要求》、《化学药品注册分类及注册资料要求》、《中兽药、天然药物分类及注册资料要求》、《兽医诊断制品注册分类及注册资料要求》、《兽用消毒剂分类及注册资料要求》、《兽药变更注册事项及申报资料要求》和《进口兽药再注册申报资料项目》 ,现予以发布 ,自 2 0 0 5年 1月1日起施行农业部发布《兽用生物制品注册分类及注册资料要求》等公告     

浅析我国兽用化学药品注册审评要求

根据《兽药管理条例》和《兽药注册办法》的规定，农业部制定了《化学药品注册分类及注册资料要求》。本文依据《兽药注册办法》，对兽用化学药品注册资料要求、审评程序和职责等方面的要求进行分析说明，供兽用新化学药品的注册、研发及生产单位参考。     

浅谈兽用化学药物质量标准建立的一般过程

兽药的质量研究与质量标准的制订是兽药研发的主要内容之一。在兽药的研发过程中需对兽药质量进行系统、深入地研究,制订出科学、合理、可行的质量标准,并不断修订和完善,以控制兽药质量,保证其在有效期内安全有效。为此,参考《兽用化学药物质量标准建立的规范化过程技术指导原则》,就兽用化学药物质量标准建立的一般过程进行了探讨,以供参考。     

农业部批准兽用新生物制品

农业部于 2 0 0 3年 4月 2 8日发布第 2 70号公告 ,根据《兽药管理条例》和《兽用新生物制品管理办法》的规定 ,经审查 ,批准中国农业科学院哈尔滨兽医研究所申报的猪传染性胃肠炎、猪流行性腹泻二联活疫苗为一类兽用新生物制品 ;中国农业科学院哈尔滨兽医研究所申报的禽网状内皮组织增殖病琼脂扩散试验抗原与阴、阳性血清和中国兽医药品监察所申报的仔猪产气荚膜梭菌病A、C型二价灭活疫苗为二类兽用新生物制品 ;中牧实业股份有限公司兰州生物药厂申报的牛口蹄疫O型灭活疫苗 (OS/99株 )为三类兽用新生物制品 ,核发《新兽药证书》 ,并发布…     

农业部442号公告公布兽药注册分类和注册要求

根据《兽药管理条例》和《兽药注册办法》的规定，农业部制定了《兽用生物制品注册分类及注册资料要求》、《化学药品注册分类及注册资料要求》、《中兽药、天然药物分类及注册资料要求》、《兽医诊断制品注册分类及注册资料要求》、《兽用消毒剂分类及注册资料要求》、《兽药变更注册事项及申报资料要求》和《进口兽药再注册申报资料项目》，并自2005年1月1日起施行。     

我国兽药行业发展现状及存在的问题

一 兽药生产企业基本状况 1 兽药生产企业数量及区域分布状况 据统计,截止2007年底,我国共批准设立1412家兽药生产企业,其中兽用生物制品企业54家,兽用化学药品企业1346家,兽用生物制品兼化学药品企业12家（见表1）。     

解读兽用生物制品注册与管理新要求

2004年国务院发布新的《兽药管理条例》,农业部针对兽药研究、注册、技术评审和行政审批等出台了《兽药注册办法》（44号令）、《新兽药研制管理办法》（55号令）、442号公告、446号公告、449号公告、683号公告、《兽药审评专家管理办法》及《兽药注册审评工作程序》等一系列配套管理规章,对兽药注册、技术审评、行政审批、专家管理、公开办事程序起到良好的指导与规范作用,使新兽药的研制、注册、生产与使用都迈上了一个新台阶。但是,就注册技术资料申报要求而言,国内外注册申请人提供的兽用生物制品注册申报资料还不能令人满意,许多申请资料很不完全,     

ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories

Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance Guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts.     

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts.     

ASVCP quality assurance guidelines: control of preanalytical and analytical factors for hematology for mammalian and nonmammalian species, hemostasis, and crossmatching in veterinary laboratories

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and provides recommendations for control of preanalytical and analytical factors related to hematology for mammalian and nonmammalian species, hemostasis testing, and crossmatching and is adapted from sections 1.1 and 2.3 (mammalian hematology), 1.2 and 2.4 (nonmammalian hematology), 1.5 and 2.7 (hemostasis testing), and 1.6 and 2.8 (crossmatching) of the complete guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts.     

Recommendations on vaccination for Latin American small animal practitioners: a report of the WSAVA Vaccination Guidelines Group

The World Small Animal Veterinary Association Vaccination Guidelines Group has produced global guidelines for small companion animal practitioners on best practice in canine and feline vaccination. Recognising that there are unique aspects of veterinary practice in certain geographical regions of the world, the Vaccination Guidelines Group undertook a regional project in Latin America between 2016 and 2019, culminating in the present document. The Vaccination Guidelines Group gathered scientific and demographic data during visits to Argentina, Brazil and Mexico, by discussion with national key opinion leaders, visiting veterinary practices and review of the scientific literature. A questionnaire survey was completed by 1390 veterinarians in five Latin American countries and the Vaccination Guidelines Group delivered continuing education at seven events attended by over 3500 veterinarians. The Vaccination Guidelines Group recognised numerous challenges in Latin America, for example: (1) lack of national oversight of the veterinary profession, (2) extraordinary growth in private veterinary schools of undetermined quality, (3) socioeconomic constraints on client engagement with preventive health care, (4) high regional prevalence of some key infectious diseases (e.g. feline leukaemia virus infection, canine visceral leishmaniosis), (5) almost complete lack of minimal antigen vaccine products as available in other markets, (6) relative lack of vaccine products with extended duration of immunity as available in other markets, (7) availability of vaccine products withdrawn from other markets (e.g. Giardia vaccine) or unique to Latin America (e.g. some Leishmania vaccines), (8) accessibility of vaccines directly by pet owners or breeders such that vaccination is not delivered under veterinary supervision, (9) limited availability of continuing education in veterinary vaccinology and lack of compulsion for continuing professional development and (10) limited peer-reviewed published scientific data on small companion animal infectious diseases (with the exception of leishmaniosis) and lack of support for such academic research. In this document, the Vaccination Guidelines Group summarises the findings of this project and assesses in evidence-based fashion the scientific literature pertaining to companion animal vaccine-preventable diseases in Latin America. The Vaccination Guidelines Group makes some recommendations on undergraduate and postgraduate education and academic research. Recognising that current product availability in Latin America does not permit veterinarians in these countries to vaccinate according to the global World Small Animal Veterinary Association guidelines, the Vaccination Guidelines Group makes a series of “pragmatic” recommendations as to what might be currently achievable, and a series of “aspirational” recommendations as to what might be desirable for the future. The concept of “vaccine husbandry” is addressed via some simple guidelines for the management of vaccine products in the practice. Finally, the Vaccination Guidelines Group emphasises the global trend towards delivery of vaccination as one part of an “annual health check” or “health care plan” that reviews holistically the preventive health care needs of the individual pet animal. Latin American practitioners should transition towards these important new practices that are now well embedded in more developed veterinary markets. The document also includes 70 frequently asked questions and their answers; these were posed to the Vaccination Guidelines Group during our continuing education events and small group discussions and should address many of the issues surrounding delivery of vaccination in the Latin American countries. Spanish and Portuguese translations of this document will be made freely available from the on-line resource pages of the Vaccination Guidelines Group.     

我国兽药产品网络销售现状及管理对策

随着电商营销的发展,兽药销售的网络平台陆续涌现,如何建立兽药网络销售准入标准、审批程序及监管措施已成为监管部门和相关企业亟需解决的课题。本文梳理了我国兽药产品网络销售现状,借鉴人用药品网络销售管理经验,建议在国家出台《中华人民共和国电子商务法》的基础上,结合《兽药管理条例》修订,完善我国兽药网络销售相关配套法规,明确第三方平台的责任义务,构建全国兽药经营企业数据库管理系统,推进兽药二维码追溯体系建设,对兽药网络营销企业分类管理和准入管理等措施,以期为提升我国兽药网络销售监管水平提供信息支持。     

伴侣动物用细胞毒类抗肿瘤药临床试验设计及评价要点

肿瘤已经逐渐发展成为老年伴侣动物最为常见的疾病，而目前国内并无伴侣动物专用的抗肿瘤药。细胞毒类抗肿瘤药是治疗恶性肿瘤的主要手段之一，目前有许多兽药企业致力于此类抗肿瘤药的研发。本文以EMA和FDA发布的伴侣动物抗肿瘤药指导原则为依据，结合国家药品监督管理局药品审评中心(CDE)发布的抗肿瘤药物临床试验技术指导原则对比分析，对伴侣动物使用的细胞毒类抗肿瘤药研发过程中的临床试验设计关键技术要点进行了分析，旨在为伴侣动物用细胞毒类抗肿瘤药临床评价提供参考。     

兽药大数据平台的应用架构研究

兽药大数据对兽药监管、兽药行业健康发展以及疫病防控具有重要意义。针对现有的兽药海量数据进行大数据应用研究,提出兽药大数据平台的应用方向和应用架构,以期为兽药大数据平台的应用发展提供参考。     

从注射剂的基本要求浅谈化药注射剂装量按规格管理的必要性

近年来我国兽用化学药品发展迅速,兽用注射剂药物品种规格不断增加.兽药规格是兽药标准规定的内容之一,它与兽药的研究、生产、使用、质量检验等密切相关.兽用注射剂规格对兽药有效性、安全性和经济性等有直接关系.因此,兽用注射剂规格的确定、增加或改变必须严格管理,综合慎重考虑兽药典要求、注册要求、生产要求等,确保兽用注射剂药物的...     

兽药临床试验质量管理规范体系的构建与应用

为加强兽药质量评价工作,切实做好兽药临床试验监督检查工作,农业农村部先后颁布《兽药临床研究质量管理规范》(农业部公告第2337号)和《兽药临床试验质量管理规范监督检查标准》及其监督检查相关要求(农业部公告第2464号).农业部第2464号公告[2]规定,自2018年1月1日起,未经我部监督检查或监督检查不合格的兽药安全...     

中国与欧盟和美国禽肉、禽蛋中兽药残留限量标准的对比研究

【目的】 为推进中国食品安全监控体系建设及完善相关的法规标准提供参考,保障食品安全的同时提升中国禽肉、禽蛋产品在国际市场的竞争力,打破国际技术性贸易壁垒,促进国际禽产品贸易繁荣发展。【方法】 首先对比分析中国新发布的食品安全国家标准GB 31650－2019《食品安全国家标准食品中兽药最大残留限量》及已废除的农业部公告第235号《动物性食品中兽药最高残留限量》中有关禽肉、禽蛋的兽药残留种类和兽药最大残留限量（MRLs）标准;然后对中国新国家标准与欧盟和美国在禽肉、禽蛋的兽药残留种类区别和MRLs标准的严宽程度等几项内容进行了对比分析。【结果】 中国新国家标准对旧标准进行了一定程度上的补充与修改,大部分有关禽肉、禽蛋的MRLs标准与欧盟和美国的标准相同甚至更加严格,这标志着中国兽药残留标准体系进入了新阶段,但部分兽药的MRLs标准仍与欧盟和美国的标准存在一定差异,其中共有包括双氯西林在内的33种兽药的MRLs标准缺失或宽于欧盟和美国。【结论】 未来中国仍需结合禽肉、禽蛋的生产情况、兽药实际使用情况及人民消费升级的需求,进一步完善禽肉、禽蛋产品中兽药残留限量的相关标准,使其向国际标准靠拢,提高中国禽肉、禽蛋产品在国际市场上的竞争力,并对进出口产品中兽药的残留情况进行严格监控,防止其影响消费者的健康安全和禽肉、禽蛋的国际贸易发展。