Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs.Methods A comparative analysis was made to study the...Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs.Methods A comparative analysis was made to study the accelerated review,conditional approval and breakthrough therapy between China and the United States.Combined with the implementation of accelerated pathway in China,some suggestions were put forward.Results and Conclusion The implementation of accelerated drug review and approval system can significantly speed up the process of new drug development,which will improve the accessibility of innovative drugs.However,there are some problems in the review procedures and the implementation of supportive documents in China.In view of the above problems and combined with the experiences of US FDA,we should strengthen the construction of institutional system and reviewer team,and improve the efficiency of drug research and development.展开更多
Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the q...Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.展开更多
文摘Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs.Methods A comparative analysis was made to study the accelerated review,conditional approval and breakthrough therapy between China and the United States.Combined with the implementation of accelerated pathway in China,some suggestions were put forward.Results and Conclusion The implementation of accelerated drug review and approval system can significantly speed up the process of new drug development,which will improve the accessibility of innovative drugs.However,there are some problems in the review procedures and the implementation of supportive documents in China.In view of the above problems and combined with the experiences of US FDA,we should strengthen the construction of institutional system and reviewer team,and improve the efficiency of drug research and development.
文摘Nowadays, CFDA has released a series of reform documents in drug registration review system, which may optimize the new drug evaluation model to accelerate the development of drugs. In this review, we summarized the qualifications and features of expedited approaches in drug review and approval in China, and compared these approaches with FDA. In conclusion, the expedited programs of drug approval in China have been gradually established and translated into policy benefits for drug makers and patients.
