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Negative continuous improvement of Chinese medicine injection quality standards is imminent
DATE:2018-03-27 18:28:23

Phase II and III clinical trials of new drugs in the United States and other developed countries have to be performed several times or even dozens of times before they are marketed. In China, they are usually marketed only once. At the same time, there are no developed country standards for the clinical evaluation of pharmaceuticals in China. In China, all clinical trials only do more than 2,000 cases, and the number of cases is relatively small. It is difficult to find adverse drug reactions. Traditional Chinese medicine injections are inherently inadequate, and drug safety is not convincing.


Since 2006, a series of adverse events in the quality of traditional Chinese medicine injections have been exposed, which has severely hit the traditional Chinese medicine injection industry. In 2009, the national traditional Chinese medicine injection re-evaluation work was fully launched, and some SMEs fell to the ground or were merged and reorganized; March 2013 4 On the day, the State Food and Drug Administration announced that more than 100,000 cases of adverse reaction monitoring reports of Chinese medicine injections nationwide in 2012, the quality of Chinese medicine injections once again caused widespread concern.


It is understood that in clinical practice, traditional Chinese medicine injections are often used in combination with other chemicals, but in practice, clinical trials of drug combinations are rarely designed during the development of new drugs, and clinical trial evaluation data are lacking; in addition, the medical level of some primary hospitals The unevenness and improper use of drugs; the lack of a systematic drug risk prevention and control system, and the lack of experience and means for emergency treatment of adverse reactions, etc., are likely to cause an increase in adverse reaction cases.


At present, multinational pharmaceutical companies have established scientific research institutions in China. Many research projects involving Chinese medicine and plant medicines are entering the Chinese new drug market, which has a great impact on local pharmaceutical companies. Of course, some adverse events are indeed caused by quality issues. For example, the incident of Ciwujia injection of Wandashan Pharmaceutical in 2008 was caused by drug contamination, but this does not mean that the quality of Ciwujia injection of all pharmaceutical companies.


The negative sound of traditional Chinese medicine injections continues, and even the top three hospitals banned traditional Chinese medicine injections. What should we do? Xiao Wei, a representative of the National People's Congress and chairman of Jiangsu Kangyuan Pharmaceuticals, pointed out that traditional Chinese medicine injections have good effects in the treatment of critical care of the cardiovascular, cerebrovascular, and respiratory systems, especially in the critical illness of influenza caused by viral infections. The advantages of substitution should be given an objective and fair evaluation of traditional Chinese medicine injections, and actively promote the application of high-quality traditional Chinese medicine injections in the field of clinical critical illness.


Some Chinese medicine injections do have quality problems, but this is only a small part. According to surveys, in recent years, some large-scale Chinese medicine injection companies have strictly controlled quality and bad quality incidents have rarely occurred. A problem with one variety will affect the entire industry. In the future, the traditional Chinese medicine injection industry should focus on restructuring the industry, increase the concentration of the industry, and raise product standards.


The industry believes that traditional Chinese medicine injections have a bright future, but relevant standards on safety, effectiveness and quality controllability should be strictly formulated. Traditional Chinese medicine injections are inherently inadequate and must be replenished the day after tomorrow. In fact, since the safety evaluation of traditional Chinese medicine injections was implemented in 2009, the awareness of improving safety and quality standards has taken root in enterprises.


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