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...

Development and Operation of GCP System of Veterinary Drugs

In order to strengthen the quality compliance of veterinary drugs and implement the supervision and inspection of clinical trials,"Good Clinical Practice(GCP)"(Announcement of the Ministry of Agriculture,No.2337),"Supervision and Inspection Standards of Clinical Trials of Veterinary Drugs"and their requirements(Announcement of the Ministry of Agriculture,No.2464)have been issued by the Ministry of Agriculture of the People's Republic of China.As stipulated by the Announcement of the Ministry of Agriculture,No.2464 effective on January 1,2018,the enterprises and institutions involved in safety examinations of veterinary drugs that have not passed/qualified the supervision and inspection,will not be allowed to apply veterinary drug registration by using their research and experimental data.Therefore,certifi cation of GCP standards of veterinary drugs is a critical requirement that hits“the throat”of the enterprises and institutions,which perform research work or safety examinations of veterinary drugs.This article summarizes th e development and operation of GCP standards of veterinary drugs,aiming to provide instructions for carrying out research and registration.Besides,this article is benefi cial to the facilities dealing with safety examinations of veterinary drugs in the process of certifi cation of GCP.