澳大利亚兽药管理与注册要求概述

通过对澳大利亚兽药管理的学习和考察,体验了其兽药管理的管理理念.对澳大利亚兽药管理体系、法律法规及兽药注册管理与要求予以概述,以期为今后我国的兽药管理与兽药注册提供参考.     

我国宠物用兽药政策法规管理体系研究

主要通过文献查阅的方式,全面梳理了我国宠物用兽药政策法规管理体系的发展概况,系统归纳了相关政策法规的主要内容与主要特点,深入分析了当前宠物用兽药管理存在的主要问题,并从制定出台综合性政策法规、完善注册审批政策、健全行业规范政策、细化执业管理政策等4个方面提出了相关建议,以期为相关主管部门健全完善宠物用兽药政策法规管理体系提供有益参考。     

加强我国兽药管理体系建设的建议

从构成兽药管理体系的兽药法律法规和标准、兽药行政管理制度、兽药检验和兽药执法监督等要素总结了我国兽药管理体系建设所取得的成效,分析了目前兽药管理体系中存在的问题,并提出了加强兽药管理体系建设的建议.     

浅谈我国兽药管理体系的建设

从构成兽药管理体系的兽药法律法规和标准、兽药行政管理制度、兽药检验和兽药执法监督等要素总结了我国兽药管理体系建设所取得的成效,分析了目前兽药管理体系中存在的问题,并提出了加强兽药管理体系建设的建议。     

欢迎订阅《浙江畜牧兽医》

《兽药注册办法》、《兽药产品批准文号管理办法》2005年1月1日实施　　经农业部常务会议审议通过的《兽药注册办法》和《兽药产品批准文号管理办法》,由农业部部长杜青林分别签署第44号、第45号令,批准发布,两部规章将于2005年1月1日实施。　　《兽药注册办法》的出台,是为了贯彻新的《兽药管理条例》,保证兽药安全有效、质量可控,进一步规范兽药注册行为。该办法草案是在多次征求有关专家、地方管理部门和社会各方面特别是兽药企业的意见基础上形成的。该《办法》明确了兽药注册分类,将兽药注册分新兽药注册和进口兽药注册两种,进口兽药注…     

兽药注册办法

第一章总则第一条为保证兽药安全、有效和质量可控,规范兽药注册行为,根据《兽药管理条例》,制定本办法。第二条在中华人民共和国境内从事新兽药注册和进口兽药注册,应当遵守本办法。第三条农业部负责全国兽药注册工作。农业部兽药审评委员会负责新兽药和进口兽药注册资料的评审工作。中国兽医药品监察所和农业部指定的其他兽药检验机构承担兽药注册的复核检验工作。第二章新兽药注册第四条新兽药注册申请人应当在完成临床试验后,向农业部提出申请,并按《兽药注册资料要求》提交相关资料。第五条联合研制的新兽药,可以由其中一个单位申请注…     

兽药注册办法

第一章总则第一条为保证兽药安全、有效和质量可控,规范兽药注册行为,根据《兽药管理条例》,制定本办法。第二条在中华人民共和国境内从事新兽药注册和进口兽药注册,应当遵守本办法。第三条农业部负责全国兽药注册工作。农业部兽药审评委员会负责新兽药和进口兽药注册资料的评审工作。中国兽医药品监察所和农业部指定的其他兽药检验机构承担兽药注册的复核检验工作。第二章新兽药注册第四条新兽药注册申请人应当在完成临床试验后,向农业部提出申请,并按《兽药注册资料要求》提交相关资料。第五条联合研制的新兽药,可以由其中一个单位申请注…     

食用动物兽药产品注册补充新规定

为加强兽药管理,保障动物源性食品安全,根据《兽药管理条例》《兽药注册办法》规定,现就食品动物用兽药产品注册要求补充规定如下。一、在我国申请注册用于食品动物的兽药产品,其有效成分尚无国家兽药残留限量标准和兽药残留检测方法标准的,注册申报时应提交兽药残留限量标准和兽药残留检测方法标准建议草案。批准兽药注册时,兽药残留限量标准(试行)和兽药残留检测方法标准(试行)与兽药质量标准一并发布实施。     

遂宁市推行“1234”工作机制强化兽药监管

正遂宁市立足兽药全产业链条监管需求,探索实施"1234"监管机制,实现生产端、销售端、使用端全过程监管,极大提升了兽药监管效能。1推行一个机制全面推行兽药追溯管理,持续健全完善生产、经营、使用全链条兽药质量追溯管理体系,做到兽药产品来源可查、去向可追。全市25家兽药生产企业的兽药产品实现"二维码"赋码上市销售,33家兽药经营企业成功注册国家兽药追溯平台,兽药产品采购、销售采集上传数据信息达到95%以上,13家规模养殖企业参加了兽药使用环节追溯体系建设试点。     

兽药行政许可实行综合办公

根据部领导要求，新年伊始，兽药行政许可实行综合办公。农业部行政审批综合办公办事指南(兽药行政许可部分)包括12项：1、研制新兽药使用一类病原微生物审批；2、兽用新生物制品临床试验审批；3、兽药生产许可证审批；4、兽药产品批准号核发；5、新兽药注册；6．进口兽药注册(兽药注册)；7、进口兽药再注册(兽药再注册)；8．兽药变更注册；9、兽药进口许可证审批；     

Legal aspects of the use of footbaths for cattle and sheep

Claw diseases pose a major problem for dairy and sheep farms. As well as systemic treatments of these illnesses by means of drug injection, veterinarians discuss the application of footbaths for the local treatment of dermatitis digitalis or foot rot. On farms footbaths are used with different substances and for various purposes. The author presents the requirements for veterinary medicinal products (marketing authorization and manufacturing authorization) and demonstrates the operation of the "cascade in case of a treatment crisis". In addition, the distinction between veterinary hygiene biocidal products and veterinary medicinal products and substances to care for claws is explained.     

欧盟兽药上市审批制度

介绍了欧盟兽药上市审批新制度:中央审批和相互认可.对这两种审批程序的法律依据、审评机构、适用范围以及具体审批过程等做一梗概说明,供我国从事兽药法规管理的相关人员参考.     

兽用化学药品血药浓度法生物等效性试验注册资料技术评审要点及常见问题

生物等效性试验作为兽药获批上市的关键试验,其研究过程和技术评审都要遵循特定的法规和指导原则。以药动学参数为终点的血药浓度法生物等效性试验是目前普遍采用的研究方法,适用于药物活性成分吸收进入体循环具有全身作用的剂型(大多数内服剂型和特殊注射剂)。本文根据生物等效性定义、相关法规和指导原则,结合近年来兽药注册资料,对血药浓度法生物等效性试验的技术评审要点及常见问题进行梳理,旨在为新兽药的研发和注册提供参考。     

Veterinary pharmacovigilance. Part 1. The legal basis in the European Union

Pharmacovigilance is a growing discipline and nowhere is this more true than in the context of the legislative requirements for veterinary pharmacovigilance within the European Union (EU), or more specifically, within the European Economic Area. Since 1995, the legislation governing the authorization of veterinary medicinal products in the EU has resulted in the older national procedures being replaced by the mutual recognition procedure and the centralized procedure. Also since 1995, the regulatory requirements for pharmacovigilance have developed and grown, as have the associated guidelines. The recent review of European veterinary medicines legislation, which concluded with the publication of an amending directive and a new regulation in March 2004, has introduced refinements to the pharmacovigilance system. This paper examines the EU legislation governing the authorization of veterinary medicinal products, including the elaboration of maximum residue limits, and the way in which this relates to the requirements of pharmacovigilance.     

The consequences of generic marketing on antibiotic consumption and the spread of microbial resistance: the need for new antibiotics

In both human and veterinary medicine, it has been shown that flooding the market with different generics and/or ‘me‐too’ branded drugs has increased overall antibiotic consumption correlating with the emergence and spread of bacterial resistance to antibiotics. Another possible undesirable consequence of the promotion of generics is the promotion of an economic incentive that encourages the use of old drug products with very poor oral bioavailability, marketed with historical dosage regimens and extensively excreted in the environment. What veterinary medicine rather needs is new innovative and ‘ecofriendly’ antibiotics to actually enforce a more prudent use of antibiotics. For a pharmaceutical company, generics are inexpensive to manufacture and on a short‐term basis, the generic market is very appealing. However, on a long‐term basis, this marketing orientation provides a disincentive to the development of new and innovative products that will be required to meet the therapeutic needs of the veterinary community while being consistent with public health concerns. Indeed, for veterinary medicine, the key issue surrounding antibiotics is public health. It is the opinion of the authors that veterinary antibiotics and/or veterinary drug formulations should be innovative in terms of selectivity (no or minimal impact on the commensal gut flora), biodegradable (with minimal environmental disruption), and more expensive, with a strictly regulated market rather than unselective, cheap, and freely available drugs.     

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...     

浅谈我国兽药行业存在的主要问题及对策

通过2008年全国兽药质量抽检结果,分析了我国兽药质量安全现状,如非法生产问题突出,含量不足、蓄意造假,经营和使用环节假劣兽药比例仍然较高等问题。剖析了兽药行业生产环节、经营环节、使用环节、兽药监督管理工作中存在的主要问题。提出了推进兽药GMP发展,规范兽药经营行为,转变政府职能,加强社会监督等措施。     

兽药监察档案现代化管理思考

兽药监察档案是兽药监察历史发展的真实记录，具有重要的原始凭证作用。针对兽药监察档案实体保存困难、查询不便等情况，就如何做好其保护和管理进行深入思考，并结合工作实际提出意见措施，以不断提高兽药监察档案现代化管理水平，更好服务新时代兽药监察事业高质量发展。     

Promoting the exotic pet practice.

The marketing and promotion of an exotic pet veterinary practice allows the use of strategies that are not necessarily available in other veterinary disciplines. The advantage that an exotics practice enjoys is that it is able to capitalize not only on the unique nature of the species being attended but also on the specialized features of the hospital itself that make it specifically appropriate in caring for exotic pets. Before marketing, however, comes the responsibility that the practice live up to the claims made in promotional materials. A practice cannot ethically be presented as an "exotics" practice if it is nothing more than a dog and cat facility that is willing to attend to exotic pets. It is the competence of the veterinary staff and the appropriateness of the facility that determines the suitability of the practice for exotics management.