亚洲社会药学

关键词: post-approval change, quality risk management, risk assessment, comparability protocol, pharmaceutical quality system

Abstract: 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.

Key words: post-approval change, quality risk management, risk assessment, comparability protocol; pharmaceutical quality system