CMC considerations of manufacturing site changes for marketed therapeutic recombinant protein drugs from regulatory review
从监管审评角度探讨上市治疗性重组蛋白药物生产场地变更的CMC考量
📄 英文摘要 English Abstract
Chinese Journal Of Biologicals 中国生物制品学杂志 With the continuous improvement of China's drug regulatory laws and regulations,Life-cycle regulatory management has become a key means and an inevitable development trend to ensure the safety of public drug use.The management of post... 随着我国药品监管法律法规的持续完善,全生命周期药品监管已成为保障公众用药安全的关键手段与必然发展趋势。已上市生物制品的药学变更管理模式已由按事项转变为基于风险的变更管理模式。近年来,已上市治疗用重组蛋白药物在生产场地变更方面的补充申请数量大幅增长,但不同情形下生产场地变更风险各异,所需开展的研究也不尽相同。本文从风险评估和分级、药学研究的一般要求与特殊情形以及申报常见问题三方面进行探讨,提出生产场地变更研究的一般要求,以期为业界提供有益参
📄 中文摘要 Chinese Abstract
📋 英文结构化总结 English Structured Summary
摘要整理
Background:
With the continuous improvement of China's drug regulatory laws and regulations, life-cycle regulatory management has become a key means and an inevitable development trend to ensure the safety of public drug use. The management of post-approval changes for marketed biological products has shifted from a matter-based to a risk-based change management model. In recent years, the number of supplemental applications for manufacturing site changes of marketed therapeutic recombinant protein drugs has increased significantly, but the risks of manufacturing site changes vary under different circumstances, and the required studies are not the same.
Methods:
This paper discusses from three aspects: risk assessment and classification, general requirements and special cases for pharmaceutical research, and common issues in applications. It proposes general requirements for manufacturing site change studies.
Results:
The paper puts forward general requirements for manufacturing site change studies based on the discussion of the three aspects.
Data Summary:
No quantitative results or key statistics are provided in the abstract.
Conclusions:
The paper aims to provide a useful reference for the industry regarding manufacturing site change studies.
Practical Significance:
The general requirements proposed in this paper can guide the pharmaceutical research and risk management of manufacturing site changes for marketed therapeutic recombinant protein drugs, thereby supporting the life-cycle regulatory management of biological products.
📋 中文结构化总结 Chinese Structured Summary
背景:
随着我国药品法律法规的不断完善，全生命周期监管已成为保障公众用药安全的重要手段和必然发展趋势。已上市生物制品的上市后变更管理已从基于事项的变更管理模式转向基于风险的变更管理模式。近年来，已上市治疗性重组蛋白药物生产场地变更的补充申请数量显著增加，但不同情况下生产场地变更的风险各异，所需研究也不尽相同。
方法:
本文从风险评估与分级、药学研究的通用要求与特殊情况、以及申报中的常见问题三个方面进行探讨，提出了生产场地变更研究的通用要求。
结果:
基于对上述三个方面的讨论，本文提出了生产场地变更研究的通用要求。
数据摘要:
摘要中未提供定量结果或关键统计数据。
结论:
本文旨在为业界提供有关生产场地变更研究的有益参考。
实际意义:
本文提出的通用要求可指导已上市治疗性重组蛋白药物生产场地变更的药学研究与风险管理，从而为生物制品的全生命周期监管管理提供支持。