从技术审查角度探讨山东省医疗机构中药制剂研发与申报

Discuss the research and development about traditional Chinese medicine preparations in Shandong Province from the perspective of technical review

中医药在临床治疗疾病过程中具有独特优势,其中医疗机构中药制剂是中医药临床应用的智慧结晶,是医疗机构特有的药品应用形式。本文通过对山东省医疗机构中药制剂相关规定的梳理,讨论了医疗机构在中药制剂研发过程中应关注的因素,列举了技术审查中发现的常见问题,对推动医疗机构临床经验方向医疗机构制剂、中药新药递级转化提出建议。

Traditional Chinese medicine has unique advantages in the process of clinical treatment of diseases,among which the traditional Chinese medicine preparations in medical institutions are the wisdom crystallization of the clinical application of traditional Chinese medicine and the unique form of drug application in medical institutions.This paper discusses the factors that medical institutions should pay attention to in the research and development process of traditional Chinese medicine preparations,lists the common problems found in the technical review,and puts forward suggestions for medical institutions to do a good job in the registration and filing of traditional Chinese medicine preparations.