药品注册核查中对技术转移方面的探讨

Discussion on technology transfer in drug registration inspection

技术转移是药品生命周期中的重要环节,是知识管理和产品质量体系的重要组成部分,技术转移的成功与否密切关系着药品的安全性、有效性和质量可控性。本文梳理了技术转移国内外相关法规指南,并结合近年在药品注册核查中发现的技术转移方面常见问题,对药学研制和生产现场注册核查要点中对技术转移的要求进行探讨,以期为药品研发单位和生产企业提供参考,为后续药品监管部门对技术转移工作的监管要求提供借鉴。

Technology transfer is an important part in life cycle of drug,as well as an important component of knowledge management and product quality system.Whether the stakeholders make successful technology transfer deeply affects the safety,effectiveness and quality controllability of drugs.Based on the relevant guidelines regarding technology transfer in China and aborad,combined with some common problems of technology transfer found in current drug pre-approval inspection,this paper proposes some suggestions on technology transfer as references for drug R&D and manufacture,and drug administration.