Research on USA and EU Regulations of Post-approval Drug Manufacturing Changes

Abstract

Abstract: Objective To put forward some suggestions on post-approval drug manufacturing changes for our country. Methods The USA and EU regulations of post-approval drug manufacturing changes were studied, and our deficiencies on post-approval drug manufacturing changes were analyzed. Results Both USA and EMA classify manufacturing changes based on risks, pay more attention to supervision of changes with high risks, and use post-approval change management protocol to give manufacturers who understand the risks of their products with more flexibility. Conclusion We should apply the risk-based approach to drug manufacturing changes to substitute the present unified regulatory way, thereby alleviate the burden of CFDA and corporations, and use post-approval change management protocol to increase more flexibility on manufacturing changes and promote manufacturs^, continuous improvement and innovation.

Key words: drug manufacturing change, risk-based approach, post-approval change management protocol

CLC Number:

R954

LI Xiao-yu, CHAI Qian-wen, TIAN De-long, YANG Yue. Research on USA and EU Regulations of Post-approval Drug Manufacturing Changes[J]. Chinese Journal of Pharmacovigilance, 2016, 13(8): 476-481.

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