Safety Report Management in New Drug Clinical Trials

Abstract

Abstract: Objective To provide proposals on strengthening and improving the safety reporting of investigational new drug(IND) clinical trials in China. Methods Based on the FDA safety reporting rules, the backgrounds, main contents, implementation effect and barriers of the final rule were thoroughly analyzed. Results The FDA IND safety report final rule clarified the terms definition, specified reporting standards, reporting time limits, and so on, so as to improve the quality of the report. Conclusion We should continue revising Good Clinical Practice(GCP), and establishing the correlation between pre-marketing and post-marketing safety information.

Key words: investigational new drug, clinical trials, safety report, final rule

CLC Number:

LIU Huan, ZHANG Zhongyi, YANG Yue. Safety Report Management in New Drug Clinical Trials[J]. Chinese Journal of Pharmacovigilance, 2019, 16(2): 88-93.

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