Objective To discuss the flexible supervision and communication mode in the post-approval change(PAC)of drugs,to explore how to ensure the quality and availability of drugs during the changes,and to provide some sugge...Objective To discuss the flexible supervision and communication mode in the post-approval change(PAC)of drugs,to explore how to ensure the quality and availability of drugs during the changes,and to provide some suggestions and reference for promoting the timely marketing of drugs.Methods Based on the comparability protocol guidelines issued by the US FDA in October 2022,the regulatory status quo of PAC between China and the US was compared to explore the feasibility of implementing comparability protocols in China.Results and Conclusion According to the specific situation of post-approval of drug change supervision,some suggestions were put forward to optimize the PAC management procedure,such as establishing the communication pathways between holders and health authorities,publishing relevant guidance and strengthening training,so as to provide reference for the implementation of comparability protocols in China.展开更多
Objective To provide suggestions for further improvement of China’s drug post-approval change management system.Methods The current legal and regulatory requirements of post-approval change management systems of drug...Objective To provide suggestions for further improvement of China’s drug post-approval change management system.Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA,EU and China were compared and analyzed.Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs.However,there are still some problems in China’s current post-approval change management systems.According to the model and requirements of the post-approval change management systems of the USA and EU,this paper proposes the following suggestions for the improvement of China’s post-approval change management system.Firstly,electronic files for licensed products should be created.Then,regulatory standards at the national level must be unified.Lastly,the concept of product life cycle management should be implemented.展开更多
文摘Objective To discuss the flexible supervision and communication mode in the post-approval change(PAC)of drugs,to explore how to ensure the quality and availability of drugs during the changes,and to provide some suggestions and reference for promoting the timely marketing of drugs.Methods Based on the comparability protocol guidelines issued by the US FDA in October 2022,the regulatory status quo of PAC between China and the US was compared to explore the feasibility of implementing comparability protocols in China.Results and Conclusion According to the specific situation of post-approval of drug change supervision,some suggestions were put forward to optimize the PAC management procedure,such as establishing the communication pathways between holders and health authorities,publishing relevant guidance and strengthening training,so as to provide reference for the implementation of comparability protocols in China.
文摘Objective To provide suggestions for further improvement of China’s drug post-approval change management system.Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA,EU and China were compared and analyzed.Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs.However,there are still some problems in China’s current post-approval change management systems.According to the model and requirements of the post-approval change management systems of the USA and EU,this paper proposes the following suggestions for the improvement of China’s post-approval change management system.Firstly,electronic files for licensed products should be created.Then,regulatory standards at the national level must be unified.Lastly,the concept of product life cycle management should be implemented.
