医疗机构中药制剂注册管理和技术要求的情况研究

医疗机构中药制剂是中药新药的重要储库。梳理医疗机构中药制剂注册和备案的管理依据,分析其一般情形,并将医疗机构中药制剂与中药新药复方制剂的现行申报资料和技术要求进行对比。旨在了解医疗机构中药制剂的品种情况及申报资料中可能存在的问题,为更好地应用人用经验,豁免来源于医疗机构中药制剂的中药新药申报资料提供参考。

Study on registration management and technical requirements of Chinese medicine preparations in medical institutions

Chinese medicine preparations in medical institutions are an important reservoir for new traditional Chinese medicines. The management basis for the registration and filing of Chinese medicine preparations in medical institutions are sorted out, and the general situation is analyzed, and the current filing information and technical requirements of Chinese medicine preparations in medical institutions and new traditional Chinese medicine compound preparations are compared. The purpose is to understand the variety of Chinese medicine preparations in medical institutions and the potential issues in the application materials, and to provide reference for better application of human experience and exemption from the application materials of new traditional Chinese medicines derived from Chinese medicine preparations in medical institutions.