title: [Pharmacovigilance idea should be introduced sufficiently into the safety monitoring and evaluation process of Chinese drugs].
abstract: Along with the general improving of public consciousness on drugs' safety and the increasing of new Chinese drugs' manufacture and application, the safety of Chinese drugs has become a more prominent concern and a focus of attention. The scientific identification, analysis and evaluation of this affairs greatly impacts the scientific decision-making for ensuring the public use of drugs in security, also influences the healthy development of Chinese medicine industry. In this paper, the different meanings of "adverse reaction" and "adverse events" of Chinese drugs were introduced from pharmacovigilance idealistic view, and the influencing factors on safety of Chinese drugs were analyzed from the perspective of pharmacovigilance. The authors proposed that "Chinese medicine safety monitoring and evaluation" is a much more practical concept in consistency with the current situation. They pointed out that introducing sufficiently the concept of pharmaco vigilance idea into the safety monitoring and evaluation process is the basis for overall evaluation and effective risk controlling of Chinese drugs.
authors: Center of Drug Re-evaluation, State Food and Drug Administration, Beijing. yty0616@hotmail.com
authors: Li
authors: L
authors: Zhang
authors: Xiao-Hui
authors: XH
authors: Yang
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D004341:Drug Evaluation / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000009:adverse effects*
chemical_list: D004365:Drugs, Chinese Herbal