OBJECTIVE To understand the new development of data integrity by drug regulatory agencies. METHODS Data integrity by drug regulatory agencies in domestic and abroad were interprated in this paper. Data integrity is critical elements of the pharmaceutical quality system, and drug regulatory agencies have issued practise /guidance on data integrity to highlight it. Practise /guidance provide a basic overview of key principles relating to data management and integrity which are regularly updated, revised and reviewed based on the feedback from review agencies, including the experience provided by various regulatory agencies and enterprises. RESULTS and CONCLUSION This paper summarizes the individual and common issues of the six major data integrity practise /guidance, explains and differentiates some concepts, which helps to understand and apply practise /guidance.
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2020, Vol. 55 
