农药境外登记GLP项目的委托及审阅策略

Audits and responses of GLP studies for international pesticide registration

GLP报告是很多农药境外登记中重要及不可或缺的硬性要求,同时也是国际认定的高标准的试验报告。出口登记的专业人员需要了解如何进行GLP项目的委托,如何应对各个国家或地区对GLP项目的要求,以及如何做好GLP报告的审阅以保证GLP报告符合登记要求。介绍了境外登记人员应该如何组织进行和进展GLP项目,重点说明了几类GLP项目中应该注意的审阅要点。

OECD GLP reports are very important and indispensable for international pesticide registration as well as the experimental reports with the highest international standard.The requirements and auditing standards for GLP studies are different in many countries and regions according to the current situation of the international pesticide market.The registration specialists have to understand these problems that may occur in the GLP studies,so as to avoid the matters in the stage of pesticide registration.This paper briefly introduces how overseas registration specialists should organize and progress GLP studies,and highlights how to audit and response in various GLP studies.