Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was us...Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was used to study the content and implementation effect of BTD system in China and the relevant policies and implementation of the same procedures of drug regulatory authorities in the United States,Japan and the European Union.Then,the differences in policies and implementation results among these countries were analyzed to provide suggestions for the implementation and optimization of this system in China.Results and Conclusion China’s BTD system is implemented late and a small number of drugs has been approved.At the same time,there are problems such as insufficient guidance and communication from the agency to applicants,a broad application condition,single review mode,and lack of full-time personnel.Both the agencies and the applicants have limited experience due to the short implementation time of BTD system in China.There are still some problems despite we have learned a lot from the experience of other drug regulatory agencies.Therefore,based on our national conditions,we should strengthen the guidance of evaluation agency to applicants,optimize the eligibility criteria of BTD system,introduce the rolling review,and increase the number of professional liaisons,which can accelerate the development and marketing process of drugs with obvious clinical value,and finally to address unmet medical need.展开更多
Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovat...Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovation in drug research and development(R&D).In this study,we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998.More particularly,we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021,as a powerful illustration of how the revolution has changed the drug R&D landscape.Innovative drug development in China has boomed,benefiting in particular from pro-innovation policies as well as expedited program designations by the authority.We found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021,with the emergence of drugs with novel mechanisms of action,including immune checkpoint inhibitors and cell therapy products.Drug lag has also been dramatically shortened by more than 70%for imported drugs in years 2016-2020 compared to years 2006-2010.Furthermore,we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China.This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.展开更多
基金Special Fund for Academy of Pharmaceutical Regulatory Sciences of Research Base for Drug Regulatory Science of National Medical Products Administration-Shenyang Pharmaceutical University(2021jgkx004).
文摘Objective To analyze the characteristics of breakthrough therapy designation(BTD)and its implementation in China,and to provide reference for the optimization of BTD system.Methods A comparative research method was used to study the content and implementation effect of BTD system in China and the relevant policies and implementation of the same procedures of drug regulatory authorities in the United States,Japan and the European Union.Then,the differences in policies and implementation results among these countries were analyzed to provide suggestions for the implementation and optimization of this system in China.Results and Conclusion China’s BTD system is implemented late and a small number of drugs has been approved.At the same time,there are problems such as insufficient guidance and communication from the agency to applicants,a broad application condition,single review mode,and lack of full-time personnel.Both the agencies and the applicants have limited experience due to the short implementation time of BTD system in China.There are still some problems despite we have learned a lot from the experience of other drug regulatory agencies.Therefore,based on our national conditions,we should strengthen the guidance of evaluation agency to applicants,optimize the eligibility criteria of BTD system,introduce the rolling review,and increase the number of professional liaisons,which can accelerate the development and marketing process of drugs with obvious clinical value,and finally to address unmet medical need.
文摘Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovation in drug research and development(R&D).In this study,we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in 1998.More particularly,we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021,as a powerful illustration of how the revolution has changed the drug R&D landscape.Innovative drug development in China has boomed,benefiting in particular from pro-innovation policies as well as expedited program designations by the authority.We found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021,with the emergence of drugs with novel mechanisms of action,including immune checkpoint inhibitors and cell therapy products.Drug lag has also been dramatically shortened by more than 70%for imported drugs in years 2016-2020 compared to years 2006-2010.Furthermore,we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in China.This review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.
