Objective To analyze the current situation of research and application of drug regulatory science in EU,and provide suggestions for policy-making of drug regulatory in China.Methods The policy guidelines issued by Eur...Objective To analyze the current situation of research and application of drug regulatory science in EU,and provide suggestions for policy-making of drug regulatory in China.Methods The policy guidelines issued by European Medicines Agency(EMA)and domestic and foreign literature were retrieved to summarize how to carry out drug regulation science in Europe.Results and Conclusion A strategic plan was formulated by the EMA for the implementation of drug regulatory science,and the construction of academic system and discourse system of regulatory science were improved,which played a role in promoting the progress of European drug regulatory science.It is suggested that a phased strategic plan of regulatory science should be established to clarify strategic objectives and main tasks in China as soon as possible.Besides,the construction of discipline system and discourse system should be strengthened to realize the scientific supervision of drugs.展开更多
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Shenyang Pharmaceutical University Research Institute of Drug Regulatory Science(2020jgkx005).
文摘Objective To analyze the current situation of research and application of drug regulatory science in EU,and provide suggestions for policy-making of drug regulatory in China.Methods The policy guidelines issued by European Medicines Agency(EMA)and domestic and foreign literature were retrieved to summarize how to carry out drug regulation science in Europe.Results and Conclusion A strategic plan was formulated by the EMA for the implementation of drug regulatory science,and the construction of academic system and discourse system of regulatory science were improved,which played a role in promoting the progress of European drug regulatory science.It is suggested that a phased strategic plan of regulatory science should be established to clarify strategic objectives and main tasks in China as soon as possible.Besides,the construction of discipline system and discourse system should be strengthened to realize the scientific supervision of drugs.
