摘要：
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.
Lv Xiaowen, Huang Zhe.
Present Situation and Enlightenment of Post-Approval Change Management of Drugs in China, USA and EU
[J]. 亚洲社会药学, 2023, 18(1): 17-23.
Lv Xiaowen, Huang Zhe. Present Situation and Enlightenment of Post-Approval Change Management of Drugs in China, USA and EU[J]. Asian Journal of Social Pharmacy, 2023, 18(1): 17-23.
