Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the sim...Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the similarities and differences of the guiding principles of US Food and Drug Administration(FDA),European Medicines Agency(EMA),and National Medical Products Administration(NMPA)on the multiplicity issues in clinical trials were compared one by one.Results and Conclusion In general,NMPA guidelines are based on ICH E9,but in detail,the guidelines of FDA and EMA focus differently on the multiplicity issues.Therefore,NMPA guidelines need to be detailed and comprehensive.NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.展开更多
Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the“14th five-year plan”to d...Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the“14th five-year plan”to deepen the reform of medical and health system.Methods A comparative analysis was made on China’s big data for regulatory science after studying the development process,operation mode,practical significance and characteristics of the big data platform for FDA regulatory science,which would help China to establish a perfect big database.Results and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United States.It is necessary to build data platforms in line with China’s national conditions through efforts in law,talents,standards,and other aspects.展开更多
Objective To study the strategic planning of drug regulatory science,the effectiveness and role of policy implementation in the United States so as to gain insights and make suggestions for further improving the strat...Objective To study the strategic planning of drug regulatory science,the effectiveness and role of policy implementation in the United States so as to gain insights and make suggestions for further improving the strategic planning of drug regulatory science in China.Methods Literature research method and comparative research method were used to compare and analyze the strategic planning of regulatory science in China and the United States.Results and Conclusion Drawing on the US experience,China should set goals based on mission and vision and identify problems,knowledge gaps,and key areas,then concrete measures can be taken to advance regulatory science.展开更多
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.Met...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 of product 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.展开更多
基金supported by the Special Foundation of Research Institute of Drug Regulatory Science,Shenyang Pharmaceutical University(2021jgkx004).
文摘Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the similarities and differences of the guiding principles of US Food and Drug Administration(FDA),European Medicines Agency(EMA),and National Medical Products Administration(NMPA)on the multiplicity issues in clinical trials were compared one by one.Results and Conclusion In general,NMPA guidelines are based on ICH E9,but in detail,the guidelines of FDA and EMA focus differently on the multiplicity issues.Therefore,NMPA guidelines need to be detailed and comprehensive.NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.
文摘Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the“14th five-year plan”to deepen the reform of medical and health system.Methods A comparative analysis was made on China’s big data for regulatory science after studying the development process,operation mode,practical significance and characteristics of the big data platform for FDA regulatory science,which would help China to establish a perfect big database.Results and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United States.It is necessary to build data platforms in line with China’s national conditions through efforts in law,talents,standards,and other aspects.
基金supported by the Special Fund of Scientific Research Base for Drug Regulation of NMPA-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(2021jgkx004).
文摘Objective To study the strategic planning of drug regulatory science,the effectiveness and role of policy implementation in the United States so as to gain insights and make suggestions for further improving the strategic planning of drug regulatory science in China.Methods Literature research method and comparative research method were used to compare and analyze the strategic planning of regulatory science in China and the United States.Results and Conclusion Drawing on the US experience,China should set goals based on mission and vision and identify problems,knowledge gaps,and key areas,then concrete measures can be taken to advance regulatory science.
文摘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 of product 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.
