Legal Issues about Drug Labeling Defects

Abstract

Abstract: ObjectiveTo propose suggestions to improve drug labeling management of China, provide reference for regulation revise. MethodsBy collecting current labeling documents in CFDA and FDA, analyze drug labeling management from legal perspective. Resultsand ConclusionCurrently, our country should clearly define drug labeling defects, make sure the standard of how to recognize labeling defects and the labeling defects liability, take steps to revise the regulations to guide drug labeling design, make the drug use safer and more effective.

Key words: labeling, defect, warning defect, legal liability

CLC Number:

R951

LI Ming-shi, YANG Yue. Legal Issues about Drug Labeling Defects[J]. Chinese Journal of Pharmacovigilance, 2014, 11(9): 542-546.

References

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