良好实验室规范(GLP)应用于我国农业转基因生物安全管理的探讨

Discussion on Good Laboratory Practice(GLP)in the Safety Management of Agricultural GMOs in China

良好实验室规范(good laboratory practice, GLP)是世界上广泛应用于医药、兽药、食品等非临床安全性评价试验的实验室质量管理体系,同时也正被世界上美国、欧盟等发达国家应用于转基因生物(genetically modified organisms, GMOs)领域。介绍了GLP的概念和基本要素,分析了其确保安全性评价数据真实性和可追溯性等主要特点,结合我国农业转基因生物产业需求,从提升转基因生物安全评价数据质量、保证转基因生物安全评价的科学性等多方面,分析了在我国农业GMOs领域中应用GLP的必要性和可行性。同时提出加快法规制定、推进GLP实验室建设、开展培训研究等5项建议,以期为转基因生物安全管理、研发和产业发展提供借鉴。

Good laboratory practice(GLP)as a test quality management system,has been widely used in non-clinical trial safety evaluation of medicine,veterinary drug and foods all over the world.At the same time,GLP has also been used in the field of management of genetically modified organisms(GMOs)by many developed countries.In this paper,the concept and basic elements of GLP were introduced,and its main characteristics such as ensuring the authenticity and traceability of safety evaluation data were analyzed.In addition,combining with the characteristics of GLP and the development requirements of agricultural GMOs,this paper analyzed the necessity and feasibility of GLP in the safety management of agricultural GMOs from the aspects of improving the data quality of safety evaluation of GMOs and ensuring the scientific nature of safety evaluation of GMOs.Based on above,five suggestions were put forward,including formulating GMOs GLP regulations,building the GLP laboratories,organizing training and research,accelerating GLP application,and promoting international cooperation,so as to provide reference for the safety management,research and development,and industry development of GMOs.