加强对药物临床试验中人类遗传资源的管理

Strengthen the management of human genetic resources in drug clinical trials

人类遗传资源样本是国家生物安全的重要屏障。药物临床试验机构通常广泛参与国际合作的药物临床试验项目,并涉及人类遗传资源采集、收集、买卖、出口出境等关键环节的管理。按照法律法规的更新不断建立健全相关管理制度,逐步达到规范管理与促进合作的目标,对我国的新药临床试验会起到很大的促进作用。本文结合法规与制度,分析了本院药物临床试验机构近年来上报遗传资源申请的审批情况,初步探讨药物临床试验机构对人类遗传资源的管理。

The management of human genetic resource is an important component of our national biosecurity.Drug clinical trial institutions widely participate in international cooperation of clinical trials and are involved in the collection,sales,export,etc. of human genetic resources. It＇s very important to refine the management system in accordance with laws and regulations, and gradually achieve the objective of standardized management and deepened cooperation,which would play a significant role in promoting new drug clinical trials in China. The purpose of this research is to preliminarily discuss the management of human genetic resource in clinical trial institutions,through laws and regulations and the analysis of approved application of genetic resources from drug clinical trial institutions in our hospital.