title: [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].
abstract: The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.
authors.affiliation: Beijing Bionovo Medicine Development Co., Ltd., Beijing 100024, China. wangxin@bionovo.com.cn
authors.forename: Xin
authors.initials: X
authors.lastname: Wang
authors.forename: Xia
authors.initials: X
authors.lastname: Su
authors.forename: Jie
authors.initials: J
authors.lastname: Yu
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
authors.forename: Yongyan
authors.initials: Y
authors.lastname: Wang
mesh_terms: D006801:Humans; D008516:Medicine, Chinese Traditional / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing