[A discussion of key issues on postmarketing reevaluation of Chinese medicine].
Because of relatively simple purposes, narrow population range, small samples, stringent controlled conditions for using medicine, and short time of clinical trials, the researches for listing approval of Chinese medicine can not draw to comprehensive conclusions on safety and effectivenes, which is not conducive to the reasonable and safe application of postmarketing Chinese medicine. Safety reevaluation is the most important issue of the postmarketing reevaluation of Chinese medicine, including adverse reaction/ incidence reporting, monitoring and evaluation three aspects, which must be taken into action with strict regulatory measures. Effectiveness reevaluation is still an important part of the postmarketing reevaluation of Chinese medicine, including reevaluation of diseases and syndromes adapted for using Chinese medicine, precise doses and appropriate treatment periods, which is an important prerequisite to ensure the safety of using Chinese medicine. At the same time, we should pay attention to the safety and effectivenes of Chinese medicine on special populations, attach great importance to postmarketing reevaluation of Chinese medicine injection, and apply appropriate research methods to carry out reevaluation studies. National drug administrative departments must strengthen management and supervision on postmarketing Chinese medicine, develop and improve policies, regulations and technical standards on the reevaluation, forming a legal basis for carrying out postmarketing reevaluation of Chinese medicine.
Xie
Yanming
Y
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Tian
Feng
F
D002681:China; D004358:Drug Therapy / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use; D006801:Humans; D011358:Product Surveillance, Postmarketing
D004365:Drugs, Chinese Herbal