Analysis of typical problems in post-marketing changes of traditional Chinese medicine in Fujian Province in past 10 years
Post-marketing change of traditional Chinese medicine is an important part of the continuous management of already listed traditional Chinese medicine,which directly affects the safety,effectiveness,and quality controllability of traditional Chinese medicine.However,in the past,post-marketing change of traditional Chinese medicine had problems such as unclear management paths and lack of research and verification,which were not conducive to improving the quality of already listed traditional Chinese medicine.To retrospectively analyze the research data on post-marketing change of traditional Chinese medicines in Fujian Province in the past 10 years,combined with communication cases and review and inspection experiences to sort out the typical problems in the research on post-marketing changes of traditional Chinese medicines,and puts forward suggestions such as paying attention to the necessity and rationality of the changes of traditional Chinese medicines,carrying out the research on changes of traditional Chinese medicines systematically and comprehensively,perfecting the guiding principles related to the changes of traditional Chinese medicines,and strengthening the change management of Chinese and western medicine compound preparations.In order to provide technical reference for marketing authorization holder to carry out post-marketing change research of traditional Chinese medicine and drug supervision departments to implement post-marketing change supervision of traditional Chinese medicine.
Fujian Provincetraditional Chinese medicinepost-marketing changetypical problemsquality control
NETL
NSTL
万方数据
