Discussion on provisions of Drug Administration Law on Chinese herbal pieces not conforming to drug standards without affecting safety and effectiveness
Discussion on provisions of Drug Administration Law on Chinese herbal pieces not conforming to drug standards without affecting safety and effectiveness
Considering the special characteristics of traditional Chinese herbal pieces,Article 117(2)of the Drug Administration Law provides special provisions for situations where traditional Chinese herbal pieces do not meet the standards and do not yet affect the safety and efficacy.This article will focus on the development of guidance documents related to Article 117(2)of the Drug Administration Law,surrounding the applicable circumstances of non-compliance with drug standards for traditional Chinese herbal pieces that do not yet affect safety and efficacy,risk assessment and enterprise recall provisions,in conjunction with the provisions of the penalty basis to analysis and discuss judicial cases of administrative penalties,so as to provide reference for strict standardized law enforcement and promote uniform law enforcement.
关键词
中药制剂/饮片/安全/治疗结果/药品管理法
Key words
Chinese materia medica preparation/herbal pieces for decoction/safety/treatment outcome/Drug Administration Law
维普
万方数据