医疗机构中药制剂调剂使用管理政策分析

Analysis of the Management Policy of Dispensing and Use of Traditional Chinese Medicine Preparations of Medical Institutions

关键词:  医疗机构  中药制剂  调剂使用  管理政策

Key words:  Medical institutions  Chinese medicine preparations  Dispensing use  Management policy

摘要:

目的：梳理国家及10个省份出台的医疗机构中药制剂调剂使用管理政策，识别当前政策特点，了解未来发展趋势，为后续推进医疗机构中药制剂调剂使用工作提供参考。方法：检索国家、省级层面政策文件，围绕调剂范围、申报程序、质量管理、监督管理等方面进行总结。结果：国家层面政策调剂范围的法律限制逐渐弱化、审批程序趋于高效，省级层面政策调剂品种范围更具探索性、主体范围进一步明确、申报程序更具操作性、责任与监管更加严格。结论：未来政策发展更要关注中药制剂质量的稳定性，完善相关研发配套条件，放宽医疗机构中药制剂调剂使用管理政策，促进向中药新药转化的发展。建议持续加强质量管理，引入风险管理理念，注重人用经验数据收集和效果评价，促进医疗机构中药制剂向中药新药转化的规范化和可持续发展。

Abstract:

Objective: To sort out the management policies on the use of traditional Chinese medicine preparations in medical institutions issued by the state and 10 provinces, identify the current policy characteristics, understand the future development trend, and provide reference for the follow-up promotion of the use of traditional Chinese medicine preparations in medical institutions. Methods: The policy documents at the national and provincial levels were retrieved, and the scope of adjustment, application procedures, quality management, supervision and management were summarized. Results: The legal restrictions on the scope of policy adjustment at the national level have gradually weakened, and the approval procedures have become more efficient. At the provincial level, the scope of policy adjustment varieties is more exploratory, the scope of subjects is further clarified, the declaration procedures are more operational, and the responsibilities and supervision are more stringent. Conclusion: In the future policy development, we should pay more attention to the stability of the quality of traditional Chinese medicine preparations, improve the relevant supporting conditions for research and development, relax the management policies for the dispensing and use of traditional Chinese medicine preparations in medical institutions, and promote the development of the transformation to new traditional Chinese medicine. It is suggested to continuously strengthen quality management, introduce the concept of risk management, pay attention to the collection of human experience data and effect evaluation, and promote the standardization and sustainable development of the transformation of traditional Chinese medicine preparations into new traditional Chinese medicine drugs in medical institutions.