Asian Journal Of Social Pharmacy

Abstract: Objective To discuss registration strategy of abbreviated new drug application (ANDA) for generic drugs in the United States from the perspective of project process and working contents of generic drug R&D and registration on the basis of project management, and to provide references for the internationalization strategy of generic drugs in China. Methods Working experience and literature review was used to analyze the content and key elements involved in the process of generic drug R&D and ANDA. Results and Conclusion Project management of generic drug from R&D to ANDA includes the working contents of each stage, such as lab R&D, scale-up R&D, technology transfer, submission for batch production, bioequivalence test and registration filling. And then periodical goals should be achieved with time scheduling and resource allocation.

Key words: generic drug, research and development, registration, USFDA