EMA关注兽用抗菌素----2份指南公开征求意见

julia朱玉姣

Use of antimicrobials in animals - public consultations on two guidelines

动物中使用抗菌药---两指南公开征求意见

The guidelines include recommendations that aim to reduce the risk of development of antimicrobial resistance in animals and to prevent transmission of resistance to humans

指南包括减少动物中抗菌耐药性发展的风险，以及防止将耐药性传给人类的建议

The European Medicines Agency (EMA) has released for public consultation two guidelines related to the assessment of antimicrobials for use in veterinary medicine.

EMA刚刚将2份与抗菌素在动物药品中的使用评估相关的指南公布征求意见。

The first guideline, drafted by the EMA’s Committee for Medicinal Products for Veterinary Use (CVMP), focuses on the assessment of the risk to public health resulting from the use of antimicrobial substances in food-producing animals.

第一份指南由EMA兽药委员会（CVMP）起始，关注焦点是食用动物中使用抗菌素物质导致的公众健康结果风险的评估。

As part of an application for marketing authorisation for antimicrobial veterinary medicines the risk of transmission of resistance to humans through food or through direct contact with livestock should be assessed. The draft guideline outlines a systematic approach for the assessment of the risks and provides advice on the required data and methodology to be used by medicine developers. The guideline is applicable to antimicrobial products that have not been previously authorised for use in food-producing animals, as well as to applications where the new authorisation can lead to increased use of antimicrobial products or to an increased risk to public health.

作为抗菌类兽药上市许可申报的一部分，需要对耐药性通过食物传递给人类，或通过家畜传递给人类的风险进行评估。指南草案中列出了风险评估的系统性方法，提供了药品开发者所用方法和所需提交数据的建议。该指南适用于之前未批准用于食用动物的抗菌素产品，同样适用于可能会导致抗菌类药品使用增加，，以及可能会导致增加公众健康风险的新上市许可

Stakeholders are invited to send their comments on this draft guideline before 31 August 2015.

相关方可以将其对指南草案的建议在2015年8月31日前提交相关部门。

The second guideline is a revised CVMP guideline for the demonstration of efficacy for veterinary medicines containing antimicrobial substances. The current guideline first came into effect in June 2003.

第二份指南是修订的CVMP关于含有抗菌物质的兽药的有效性证明指南。现行指南是2003年6月生效的。

The revision aims to provide guidance on the development of new veterinary antimicrobials while taking into account the risk of development of antimicrobial resistance and the need to promote the responsible use of these substances.

修订目的是对新的兽用抗菌素研发提供指南，同时考虑抗菌素耐药性的发展风险，以及促进负责任地使用这些物质的需要。

The revised guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy of antimicrobial veterinary medicines. The document presents methods to identify and describe the pharmacology of active substances in preclinical studies and outlines important aspects on the use of a certain substance for a particular indication.

修订后的指南为支持抗菌素兽药的临床有效性的临床前和临床研究设计和实施提供指南。文件中给出的方法用于识别和描述活性物质临床前研究中的药理学，列出了特定物质在特殊症状使用的重要方面。

The public had been consulted on a first revision of this guideline already in 2013. This was followed by a focus group meeting with stakeholders to discuss certain aspects of the proposed revisions and to address concerns raised during the consultation phase.

该指南第一份修订稿已于2013年公开征求意见。之后与相关方有一个专题会议，讨论了所提议的修订内容的一些方面，说明了在征求意见期间收到的关注问题。

This second revision provides further information on the use of veterinary antimicrobials in animals that are at risk of being infected (methaphylactic use). The document also clarifies the study requirements for antimicrobials that should be reserved for certain situations only.

这次的第二修订稿提供了关于兽用抗生素使用对动物产生的影响的风险（抽象使用）的更多信息。该文件还澄清了抗菌素研究应限制在特定情形的要求

Stakeholders are invited to send their comments on this draft guideline by 31 May 2015.

相关方可以在2015年5月31日前将对该指南草案的建议提交相关部门。

Comments on both guidelines should be sent to vet-guidelines@ema.europa.eu using the forms provided.

两份指南的建议均可通过提供的表格发送至上述邮箱。

土豆王

感谢楼主分享!

beiwei5du

学习了！谢谢julia,“methaphylactic use”翻译成“抽象使用”感觉不是很合适呢？个人认为应该翻译成“群体预防”。“下图选自wikipedia。同时在互联网上看到这么两句：
1、metaphylaxismetaphylaxisthe timely mass medication of a group of animals to eliminate or minimize an expected outbreak of disease.

2、It is not uncommon for veterinarians to give antibiotics to animals that are not currently ill with a particular disease, but are at high risk of acquiring an infection.  For example, an animal may be treated with antibiotics after having undergone surgery or injurious trauma (prophylaxis) or herds and flocks may be given antibiotics if they are at risk of suffering an outbreak of infectious disease due to exposure to disease agents or extremely unfavorable host or environmental conditions (metaphylaxis).  In companion animal veterinary medicine, antibiotics are commonly used to control secondary bacterial invasions such as during surgical procedures and managing infection-promoting disease conditions such as urolithiasis.  In poultry and livestock, mass administration of antibiotics is often practiced when transporting or moving young animals, during dry-cow therapy in dairy cows and in preventing respiratory and intestinal maladies when animals have been subjected to severely stressful conditions.
prophylaxis是指在个体动物接受治疗时的预防，而metaphylaxis是指为发病前的“群体预防"。