新兽药安全评价与评审

New Veterinary Drug’s Evaluation and Safety Assessment

关键词:  新兽药，安全评价，风险评估，评审

Key words:  New Veterinary Drug, Safety assessment, Risk assessment, Approval evaluation

摘要:

文章对国际上兽药安全评价与风险评估的概念与内容，新兽药研发流程与安全性评价流程，新兽药评审与评价区别进行了论述，并对新兽药安全性评价研究工作目的与结果评价，风险评估与食品安全，特别是每日允许摄入量（ADI）制订和最高残留限量（MRL）的制订等方面进行了论述，对国内企业开发用于食用动物的新兽药有一定指导作用。

Abstract:

This article introduced the global concept and content of safety assessment and risk assessment on new veterinary drug, flowchart for research and development of new veterinary drug and safety assessment, difference between new veterinary drug’s evaluations and appraisal. The objectives and estimation on result from safety assessment on new veterinary drug, the relationship of risk assessment and food safety, especially the establishment of acceptable daily intake and maximum residue limit were also introduced. It will help to provide the guidance for the industry in China to develop new veterinary drug used in food producing animals.