[Expert consensus on the design and implementation of clinical safety centralized monitoring study of Chinese medical injection]

Zhongguo Zhong Yao Za Zhi. 2017 Jan;42(1):6-9. doi: 10.19540/j.cnki.cjcmm.2017.0003.
[Article in Chinese]

Abstract

Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.

Keywords: Chinese medical injection; centralized monitoring; safety evaluation.

MeSH terms

  • China
  • Consensus
  • Drug-Related Side Effects and Adverse Reactions
  • Drugs, Chinese Herbal / adverse effects
  • Drugs, Chinese Herbal / standards
  • Humans
  • Injections
  • Medicine, Chinese Traditional / standards*
  • Product Surveillance, Postmarketing*
  • Quality Control

Substances

  • Drugs, Chinese Herbal