Abstract：OBJECTIVE Under the background of the requirements for improving the quality of generic drugs and promoting the development of generic drugs proposed by the reform of drug review and approval. To discuss FDA′s complex generic drug registration communication system and puts forward suggestions on the communication mechanism of drug registration in China. METHODS The paper introduces the FDA′s regulatory policies from the scope of complex generic drugs, the types of communication meetings and the relevant requirements of the meetings, and analyzes the scope of drug registration communication in China. RESULTS Use comparative research to outline FDA′s complex generic drug registration communication system, including the scope of complex generic drugs, the types of communication meetings and the relevant requirements, and then analyze the deficiencies of the drug registration communication system in China. CONCLUSION In combination with the existing management requirements for drug registration communication, it is suggested to further refine the categories of communication meetings, supplement and improve the requirements for communication meetings, clarify the management requirements for complex generic drugs, guide and standardize the generic drugs registration, improve the quality of generic drug application, and effectively meet the clinical needs of high-quality generic drugs.
崔晶, 董旻, 吕旭峰, 张宁. 美国FDA复杂仿制药注册沟通交流制度研究及启示[J]. 中国药学杂志, 2022, 57(24): 2135-2138.
CUI Jing, DONG Min, LÜ Xu-feng, ZHANG Ning. FDA′s Complex Generic Drug Registration Communication System and Its Enlightenment. Chinese Pharmaceutical Journal, 2022, 57(24): 2135-2138.
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2022, Vol. 57 
