Research on FDA Bioresearch Monitoring Inspection System and Its Enlightenment to China
ZANG Ke-cheng1,2,3, DU Yi1,2, SHAO Rong1,2*
1. Institute of Regulatory Science, China Pharmaceutical University, Nanjing 211198, China; 2. NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, Nanjing 211198, China; 3. Center for Food and Drug Inspection of NMPA, Beijing 100044, China
Abstract：OBJECTIVE To study the FDA bioresearch monitoring inspection system and the problems in China's drug research inspections. METHODS This article studied the laws and regulations, guideline basis, inspection procedures, inspection types, inspection points and common inspection defects. First, we searched the regulatory guidelines and research literature of the bioresearch monitoring inspection system, then we collected the fiscal year work status reports of the bioresearch monitoring inspection system published on the FDA website. RESULTS The bioresearch monitoring inspection system has a complete set of guidelines as a guide, a specialized team of inspectors to perform inspections, and an internal information platform, eNSpect, to assist inspectors in their inspections. Different types of inspections are clearly delineated, inspection points are clearly defined, and annual inspections as well as common inspection defects are released in a timely manner. CONCLUSION It is suggested that China should establish a perfect drug development inspection guideline system, strengthen the inspector team, and construct internal information platform.
臧克承, 杜怿, 邵蓉. 美国FDA生物研究监查检查体系对我国的启示[J]. 中国药学杂志, 2022, 57(4): 321-326.
ZANG Ke-cheng, DU Yi, SHAO Rong. Research on FDA Bioresearch Monitoring Inspection System and Its Enlightenment to China. Chinese Pharmaceutical Journal, 2022, 57(4): 321-326.
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