论文部分内容阅读
为进一步加强兽药质量评价工作,确保兽药安全有效,根据《兽药管理条例》规定,我部组织制定了《兽药临床试验质量管理规范》,现予公布,自公布之日起施行。特此公告。附件:兽药临床试验质量管理规范2015年12月9日附件兽药临床试验质量管理规范第一章总则第一条为规范兽药临床试验过程,确保试验数据的真实性、完整性和准确性,根据《兽药管理条例》制定本规范。第二条兽药临床试验质量管理规范(以下
In order to further strengthen veterinary drug quality evaluation and ensure veterinary drugs are safe and effective, according to the Regulation of Veterinary Drugs Management, MOFCOM has formulated the “Code of Quality Management for Clinical Trials of Veterinary Drugs” and is hereby promulgated and will come into force as of the date of promulgation. Special announcement. Annex: Quality Control of Clinical Trials for Veterinary Drugs December 9, 2015 Annex Rules for Quality Management of Clinical Trials for Veterinary Drugs Chapter I General Provisions Article 1 In order to standardize the veterinary drug clinical trial process and ensure the authenticity, completeness and accuracy of test data, Veterinary Drugs Regulations "to develop this specification. Second veterinary drug clinical trial quality management practices (below