| 摘要: |
| 分析了国家标准的概念、我国兽医生物制品标准体系的构成，介绍了我国兽医生物制品标准体系的历史和现状，指出了现阶段我国兽医生物制品标准化工作中存在问题及其原因，提出了统一认识，按照全新思路开展《兽药典》制定工作，加强对企业标准的备案审查工作，做好疫苗效果评价用强毒株筛选工作，完善相关法律法规并做好与标准体系的衔接工作5项建议。 |
| 关键词: 兽医生物制品 标准化 标准体系 国家标准 企业标准 |
| DOI： |
| 投稿时间：2015-11-11修订日期：2015-12-03 |
| 基金项目: |
|
| Research and Reflection on Construction of the Standard System of Chinese Veterinary Biological Products |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| The concept of national standard and components of standard system of veterinary biological products were analyzed. The history and current situation of the standard system of Chinese veterinary biological products were introduced. The existing problems in veterinary biologics standardization and their reasons were pointed out. Corresponding countermeasures proposed include unifying understanding; taking whole new measures to formulate new edition of Veterinary Pharmacopoeia; strengthening review mechanism for enterprise standards; designating virulent strains used in efficacy tests of veterinary vaccines; improving our legal system to make it compatible with the new standard system. |
| Key words: veterinary biological products standardization standard system national standard enterprise standard |
