RESUMO
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.
Assuntos
Medicina Tradicional Chinesa/normas , Vigilância de Produtos Comercializados , China , Consenso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/normas , Humanos , Injeções , Controle de QualidadeRESUMO
The discussion centered primarily on background, basis and research ways of the study on producing area suitability of genuine traditional Chinese drugs in this paper. The authors expounded application and development of the used modem techniques. The direction and strategy of producing area suitability of genuine traditional Chinese drugs for the future were proposed and prospected aiming to provide with scientific thoughtway and guiding later production and practice.