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本文根据国家食品药品监督管理总局有关文件和现阶段已经开展技术审评工作情况,结合笔者的理解,对中药药品技术转让过程中在药品证明信息、处方研究、生产工艺、质量研究、稳定性研究等方面存在的共性问题进行探讨、分析,并对企业如何避免在中药技术转让过程中出现相关问题给出了建议,以期降低转让过程中存在的风险,确保技术转让品种质量的一致性,推动新修订的药品GMP的顺利实施。
In this paper, according to the State Food and Drug Administration of the relevant documents and technical review work has been carried out at this stage, combined with the author’s understanding of the Chinese medicine technology transfer in the process of drug certification information, prescription research, production technology, quality research, stability studies And other aspects of the common problems to explore, analyze, and how to avoid enterprises in the transfer of traditional Chinese medicine technology-related issues appear to give recommendations to reduce the risk of transfer of the process to ensure that the quality of technology transfer varieties of consistency and promote the new The revised implementation of the drug GMP.