目的：为我国关联审评审批政策下药用辅料与药包材变更管理制度的实施提供参考。方法：简要介绍了中国、美国、欧盟及日本药用辅料和药包材的管理政策，研究和梳理药用辅料和药包材变更管理制度。结果与结论：在关联审评审批制度下，药品制剂注册申请人需更加关注药用辅料和药包材对制剂质量的影响，应将药用辅料和药包材科学合理地纳入药品全生命周期管理。当药用辅料和药包材发生变更时，申请人需开展风险评估，研究变更所涉及的研究验证工作，并提供相关的研究信息。从行业监管的角度，应尽快出台相应的法规和技术要求，以加强指导。
Objective: To provide references for the change management of pharmaceutical excipients and pharmaceutical packaging materials after the implementation of the associated review & approval policy in China. Methods: The management policies of pharmaceutical excipients and pharmaceutical packaging materials in China, Europe, America and Japan were introduced in brief, and the change management of pharmaceutical excipients and pharmaceutical packaging materials in China were provided, by studying and sorting out the change management system in this regard. Results and Conclusion: Under the system of associated review & approval, drug applicants should pay more attention to the influence of pharmaceutical excipients and pharmaceutical packaging materials on the quality of preparations, and scientifically and reasonably integrates pharmaceutical excipients and pharmaceutical packaging materials into the whole life cycle management of drugs. When pharmaceutical excipients and packaging materials are changed, the applicant shall conduct risk assessments, investigate the research validation involved in the change, and provide relevant research information. From the perspective of industry supervision, relevant regulations and technical requirements should be issued as soon as possible to strengthen guidance.
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