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    Home > Active Ingredient News > Drugs Articles > State Food and Drug Administration: to require Chinese medicine enterprises to strengthen the evaluation of Chinese medicine resources

    State Food and Drug Administration: to require Chinese medicine enterprises to strengthen the evaluation of Chinese medicine resources

    • Last Update: 2017-10-13
    • Source: Internet
    • Author: User
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    [China Pharmaceutical network industry trends] before the National Day holiday, the State Food and Drug Administration issued a circular to recall the corresponding batches of Xiyanping and Honghua injection, which immediately pushed the quality and safety problems of traditional Chinese medicine injection to the public opinion The primary cause of adverse reactions induced by traditional Chinese medicine injection is the instability of raw materials Due to the different producing areas, soil quality, climate, harvest season and other planting conditions, the ingredients may be quite different, and the difference of the same medicinal material from different sources is even greater On October 11, the State Food and Drug Administration issued a notice to solicit opinions on the technical guidelines for the evaluation of traditional Chinese medicine resources It is proposed to require Chinese medicine manufacturers to reevaluate Chinese medicine resources every five years, involving all industrial production of Chinese medicine represented by Chinese patent medicine, Chinese herbal pieces and Chinese herbal formula granules The Notice includes the technical guidelines for the evaluation of traditional Chinese medicine resources (Draft for comments) and the drafting instructions According to the draft of guiding principles for the evaluation of traditional Chinese medicine resources (Draft for comments), the evaluation of traditional Chinese medicine resources includes not only the evaluation of output, but also the evaluation of quality The main purpose of output evaluation is to ensure the accessibility of raw materials for enterprise production, and the main purpose of quality evaluation is to ensure the stability and controllability of raw materials for enterprise production According to the guiding principles, the production enterprises shall define and fix the basic source, source area, collection time, processing method, etc If it comes from artificial cultivation, it shall also explain the measures that the cultivation meets the requirements of the production quality management standards of Chinese herbal medicines It can be seen that as long as the evaluation of traditional Chinese medicine resources involves the scope of quality evaluation, it will have a huge impact on the production enterprises of Chinese patent medicine, Chinese herbal pieces, Chinese herbal formula granules, etc ▍ the quality of traditional Chinese medicine is worrying According to the data of China food and drug inspection and Research Institute, the national drug quality sampling and monitoring from 2013 to 2016 showed that the overall qualification rates of traditional Chinese medicine and decoction pieces were 64%, 68%, 75% and 77%, respectively That is to say, a quarter of Chinese herbal medicines are unqualified Professionals said that the use of substandard Chinese medicine, the production of substandard Chinese patent medicine In the past, traditional Chinese medicine paid special attention to the authenticity To collect it in the original place of the deep mountains and forests, the quality is of course beyond reproach Now, 90% of Chinese herbal medicines come from artificial cultivation Without wild and original environment, the authenticity of medicinal materials will be greatly reduced And China is now a big country of pesticides Many kinds of herbs can't be taken directly In particular, some traditional Chinese medicine planting enterprises blindly pursue economic benefits, abuse chemical fertilizers and pesticides, reduce the growth period, resulting in changes in drug properties, do not meet the Pharmacopoeia standards, and toxic and side effects are also excessive ▍ impact of raw materials on traditional Chinese medicine injections before the National Day holiday, the State Food and Drug Administration issued a circular to recall the corresponding batches of Xiyanping and Honghua injections, which immediately pushed the quality and safety problems of traditional Chinese medicine injections to the public opinion Professionals said that for the quality and efficacy of Chinese patent medicines, especially traditional Chinese medicine injections, the use of genuine herbal medicine production is very important The primary cause of adverse reactions induced by traditional Chinese medicine injection is the instability of raw materials Due to the different producing areas, soil quality, climate, harvest season and other planting conditions, the ingredients may be quite different, and the difference of the same medicinal material from different sources is even greater The instability of the quality of traditional Chinese medicine often results in the quality difference between batches of traditional Chinese medicine injections, which leads to different adverse reactions ▍ the cost of traditional Chinese medicine is going up again! From the above analysis, we can see that the quality of traditional Chinese medicine and its authenticity are particularly important for traditional Chinese medicine, especially for traditional Chinese medicine injection The correct place of origin is undoubtedly an important guarantee for the quality of traditional Chinese medicine Therefore, the guiding principles put forward the requirements of fixed place of origin for production enterprises, and advocated the use of genuine medicinal materials If Chinese patent medicine, Chinese herbal pieces, Chinese herbal formula particles and other enterprises use genuine herbs in the production process, then the production cost of relevant enterprises will surely rise Why? Since the implementation of Pharmacopoeia 2015, the cost of processing and storage of sulfur-free medicinal materials has increased, which has become a rare shortage in the market More and more sulfur-free medicinal materials have increased in price Secondly, in recent years, the ecological damage and the strong demand of foreign markets have led to the decline of the quality of many domestic traditional Chinese medicine medicines, some of which can only be called "medicinal dregs", and authentic medicine is a scarce product Moreover, in recent years, the price of traditional Chinese medicine has been "singing all the way" Bozhou, as a large distribution center of traditional Chinese medicine, saw an average increase of more than 30% in the price index of traditional Chinese medicine in 2016, some of which even doubled or more than tripled In this market, in addition to the "guiding principles" for the production of enterprises put forward the requirements of fixed place of origin, the use of authentic medicinal materials, then, Chinese patent medicine, Chinese herbal pieces, Chinese herbal formula particles and other production enterprises will usher in another wave of cost increases Original title: the general administration plans to require traditional Chinese medicine enterprises to strengthen the evaluation of traditional Chinese medicine resources, teach you to use app (Pharma) in the whole process, seize the opportunity of pharmaceutical machinery
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