广东省医院制剂质量标准提高现状及问题浅析

Analysis on the Current Situation and Related Problems of Improving the Quality Standard of Hospital Preparations in Guangdong Province

目的:为促进医院制剂质量标准提高及可持续发展提供参考。方法:基于广东省医院制剂近年质量标准提高工作概况,结合广州中医药大学第一附属医院制剂质量标准提高工作及再注册中发现的常见问题及原因,总结提高医院制剂质量标准的对策,探讨医院制剂发展思路。结果与结论:经过本轮质量标准提高工作,广东省及我院制剂的质量控制水平有较大提高,但医院制剂普遍存在硬件建设投入大、利润低、研究人才匮乏、新制剂研发难度大等困难。建议政府部门制订促进医院制剂发展的政策,医疗机构加强软硬件建设、特色制剂的研发与新药转化,注重开展医院制剂的不良反应监测,不断提升医院制剂的安全性、有效性和质量可控性,共同促进医院制剂的可持续发展。

Objective:To provide reference for the improvement of hospital preparation quality standard and sustainable development.Methods:Based on the current work overview of the improvement of the quality standard of hospital preparations in Guangdong Province in recent years,combined with the problems encountered in the improvement of quality standard of hospital preparationsand re-registration status in the frist affiliated hospital of Guangzhou university of TCM,the countermeasures to improve the quality standard control of hospital preparations were analyzed,and the development ideas of hospital preparations were discussed.Results&Conclusion:After this round of quality standard improvement,the quality control level of hospital preparations in Guangdong Province and our hospital has been greatly improved,but there are many difficulties in the development of hospital preparations,such as large investment in hardware construction,low profit,lack of research talents,and great difficulty in research and development of new preparations.It is suggested that government departments should formulate policies to help the development of hospital preparations,and medical institutions should strengthen the construction of software and hardware,the research and development of characteristic preparations and the transformation of new drugs,pay attention to the monitoring of adverse reactions of hospital preparations,and continuously improve the safety,effectiveness and quality controllability of hospital preparations,so as to jointly promote the sustainable development of hospital preparations.