2008年6月,国家食品药品监督管理局发布实施了《药品注册现场核查管理规定》,规定中要求省级药品监管部门应当对所受理药品注册申请的临床试验情况实施现场核查,旨在对临床试验情况进行实地确证,对原始记录进行审查,确认申报资料的真实性、准确性和完整性,同时明确了现场核查的要点。现就以下几个重点方面对核查要点和常见问题进行介绍。 In June 2008, the State Food and Drug Administration promulgated the Provisions on the Administration of Field Verification of Drug Registration, which stipulated that provincial drug regulatory departments should conduct on-the-spot verification of clinical trial applications for drug registration applications, The test was verified on the spot, the original records were reviewed to confirm the authenticity, accuracy and completeness of the application materials and the key points of on-site verification. Now on the following key aspects of the verification points and common issues are introduced.