A comparative progress and prospect for drug technological guidances system in China

doi:10.19803/j.1672-8629.20220351

Abstract

Abstract: Objective To provide some benefit references for being perfected to the Drug Technological Guidances System and promotes drug quality assurance mechanism. Methods By consulting regulations and literatures, the published drug technological guidances by National Medical Products Administration(NMPA), Food and Drug Administration (FDA) and European Medicines Agency (EMA) were compared, and the development status and practical experience of China's drug technical guidelines in recent years were reviewed. Results and Conclusion The countermeasures and suggestions for strengthening drug technological guidances system in china are put forward.

Key words: drug technological guidances system, drug technological guidances, drug registration, drug quality management in review

CLC Number:

R954

SHA Mingquan, ZHANG Yawei, ZHOU Hongjie, WEN Baoshu. A comparative progress and prospect for drug technological guidances system in China[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1045-1049.

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