Tracking safety of injection of traditional Chinese medicine re-evaluation – TCM injections, security – the pharmaceutical industries
Houttuynia events, Acanthopanax event Yinzhihuang event Shuanghuanglian Event … … was considered a breakthrough in the modernization of Chinese medicine TCM injections Frequent accidents, safety, caused widespread controversy in society, or even disable some hospitals of TCM injections. As in Medicine An important part of culture, the development of traditional Chinese medicine injection what go? Country Food And Drug Administration recently issued one after another "on the safety of traditional Chinese medicine injection well further evaluation," and other series of documents, start a comprehensive evaluation of traditional Chinese medicine injection and then for the development of traditional Chinese medicine injection clear direction. Frequent incidents of
phytotoxicity into the Death of TCM injections
"TCM injections of historical status and current issues, ask us to traditional Chinese medicine as soon as possible re-evaluation of injection safety." Speaking of TCM injections re-evaluation of the necessity and urgency, the State Food and Drug Administration Deputy Wu Zhen, the Secretary says.
Recent years, as production and quality control reasons, the quality of TCM injections frequent security incidents. Data show that traditional Chinese medicine injection Adverse reaction The incidence and severity of adverse reactions are far greater than the varieties of traditional Chinese medicine.
According to the National Adverse Drug Reaction Monitoring Center, in the case received reports of adverse drug reactions, the Chinese case report adverse events reported only cases of the same period in 11.68% overall, but traditional Chinese medicine injection case reports of adverse events account for the total cases reported 72.64 percent of Chinese medicine, including serious adverse events reported serious cases of Chinese medicine accounted for 76.57 percent reported.
However, another set of data, as an innovative dosage forms of traditional Chinese medicine, traditional Chinese medicine injection in clinical use is growing rapidly. According to statistics, from 1999 to 2006, the national traditional Chinese medicine injection market, the average growth rate of more than 30%, 2008 Sell Top ten varieties of proprietary Chinese medicines, traditional Chinese medicine injections accounted for six of them.
Present, traditional Chinese medicine injection industry sales have more than 20 billion yuan, 400 million passenger trips each year medicine injections. TCM injections have become a unique means of clinical diseases, particularly cardiovascular and cerebrovascular diseases, anti-tumor, anti-virus as well as some emergency treatment areas, are playing an important or even irreplaceable role.
Urgent investigation and risk to ensure Become a Hot
"Can not deny some specific questions on traditional Chinese medicine injection, injection of Chinese medicine a comprehensive evaluation is to improve the quality of traditional Chinese medicine injection level of protection, and promote the healthy development of traditional Chinese medicine injection." Wu Zhen said.
Drugs further evaluation is the safety of drugs already on the market, the effectiveness of the investigation, analysis, recognition process. China 1985 issued by "The People's Republic of China Drug Administration Law" (referred to as the Drug Administration Law) has proposed to the production of drugs that have been approved for re-evaluation of the 2000 amendments to the "Drug Administration Law" of drug re-evaluation of the requirements put forward further . But over the years, China carried out only in cases of re-evaluation of drugs, a class of drugs has not been systematic and comprehensive re-evaluation.
Wu Zhen said that the State Food and Drug Administration decided this year as the first batch of traditional Chinese medicine injection re-evaluation of varieties, it is necessary in order to explore ways to gain experience, establish a standardized, systematic re-evaluation.
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