摘要：
Objective To sort out the focus areas of FDA’s scientific supervision and to achieve corresponding results, so as to provide some suggestions for the scientific research and innovation of drug supervision in China. Methods In-depth research was carried out in the fields of safety evaluation tools, clinical trial innovation, new methods ofproduct quality evaluation, information science and so on. Results and Conclusion The research foundation of drug supervision related technology in China is weak, and a systematic supervision system has not been formed. Learning from the scientific experience of drug supervision in the United States, we can promote the development of the focus areas of drug supervision in China. Besides, we should improve the standard management ability while perfecting the regulations and standards system. Lastly, we should establish a system for government and industry-university-research to realize the full-cycle supervision of drugs.
Gong Jingran, Chang Senhao, Chang Yingnan, Chen Yuwen.
Research Progress in FDA’s Focus Areas of Regulatory Science for Drugs and Suggestions for China
[J]. 亚洲社会药学, 2023, 18(3): 191-197.
Gong Jingran, Chang Senhao, Chang Yingnan, Chen Yuwen. Research Progress in FDA’s Focus Areas of Regulatory Science for Drugs and Suggestions for China[J]. Asian Journal of Social Pharmacy, 2023, 18(3): 191-197.
