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| The new pharmacopoeia is expected to be able to complement the estimated 6,400 drug standard shortboards |
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| Author：中国铭铉 企划部 Release Time：2017-9-18 11:15:34 Number Browse：1010 |
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Medical network - on September 18, at present, China's pharmaceutical standards field there are many short board, a new version of "pharmacopoeia of the People's Republic of China" in contains no longer blindly pursue quantity on drug varieties, but pay more attention to quality. In the future, the variety of pharmacopoeia will be in and out of the future, so that it can promote the healthy development of the whole industry
Recently, the national pharmacopoeia committee held a press conference announced that considering the national drug standards, on the basis of overall situation, will be introduced in 2020, the 11th edition of the "pharmacopoeia of the People's Republic of China contains varieties of drugs for up to 6400 or so. Among them, additional Chinese medicine, chemical medicine, biological products and other varieties about 800.
"Pharmacopoeia is a country to ensure drug quality, index of technical regulations about the quality of the drug, the pharmacopoeia standard is the basis of drug quality inspection and evaluation, is also the foundation of guarantee safe and effective drug." Zhang wei, secretary general of the national pharmacopoeia commission, said that the 2015 edition of the pharmacopoeia of the People's Republic of China is the 10th edition of the pharmacopoeia since the founding of the People's Republic of China. The total number of drugs in this edition is 5608, covering basic drugs, medical insurance catalog varieties and other contents, which can be adapted to the needs of clinical medicine.
Zhang wei said that the 2020 edition pharmacopeia proposed contains varieties of moderate growth requirements, one is to consider the adjustment of the directory, the second is the tone of the contains the drugs work, to pay attention to the inherent quality of drug promotion, which no longer blindly pursue quantity, but more emphasis on quality. On the one hand, high quality products will be used as the benchmark, and high standards will be established. Through research, on the other hand, to find the problem such as listed in the drug standard absent or imperfect, filling, further improve the quality of the listed drug control level, improve the safety and efficacy of the drug.
Specific terms, the drug standards, mainly is the standard, backwardness of standard, regardless of use, standard implementation does not reach the designated position in some concrete problems such as breed or type of varieties exist in different degrees. The reason is that the drug market standard is not high, and the original products are not used as reference preparation. For example, in terms of the safety of Chinese medicinal materials and yinpian control, although for pesticide residues, heavy metals and harmful elements with detection method, but for specific kinds of detection limit due to the lack of big data accumulation and analysis, can't make a set of science.
"The revision of drug quality standards is a complex process, especially for traditional Chinese medicines with relatively complex components. The difficulties and challenges are self-evident." Analysis of zhang wei said that in recent years, with the expansion of the industrialization and marketization and upgrade, the fast development of Chinese herbal medicine industry in China, but the Chinese herbal medicine and yinpian market shoddy, doping ShiJia industries "hidden rules", and some herbs excessive pesticide residues, heavy metals and harmful elements such as problem seriously affects the safety of Chinese medicinal materials quality, hindered the healthy development of Chinese traditional medicine industry and the cause of Chinese medicine.
For public safety, also in order to better serve the cause of traditional Chinese medicine, the 2020 edition of pharmacopoeia of 2015 edition pharmacopoeia contains variety 618 kinds of herbs (yinpian specifications 823) system, continue to study and set up heavy metals and harmful elements, pesticide residue and mycotoxins exogenous harmful material such as high sensitivity analysis method and testing technology and its evaluation standard, to further improve the detection of traditional Chinese medicine standard project, the key to improve the quality of Chinese medicine yinpian standard research and develop.
In addition, the new pharmacopoeia will further improve the standard system and strengthen the concept of whole-process management of drug quality. To this, zhang wei also revealed that the new pharmacopoeia will improve and enrich the connotation of drug standards, strengthen the process control, controlled by drug terminal to the production process and source control, realize the drug quality control standard system of the life cycle.
, for example, the new pharmacopoeia will create horizontal cover Chinese medicine, chemical medicine, biological products, active pharmaceutical ingredients, pharmaceutical excipients, medicine packaging material quality control, technical requirements and standards, longitudinal covering pharmacopoeia notice, the general principles of the preparation, general, the general principles of the test methods and guiding principles, and gradually strengthen and perfect the related to drug research and development, production, distribution and use of general technical requirements and guidelines of drug standards system.
The national pharmacopoeia commission will also establish a national drug standard elimination mechanism. "The collection of pharmacopoeia will adhere to the principle of optimizing the increment and reducing the stock, and the quantity should be increased appropriately and the quality will not be more." According to zhang wei, the selection principle of improving the entry and exit of pharmacopoeia should be established to eliminate some backward products and backward standards. That is to say, the standard will "have to have a", for an approval number has been cancelled, long-term don't production, quality control, dosage form is not reasonable, the stability is not high pharmaceutical standards of "subtraction", so as to realize standard, thoroughly solve longstanding problems in pharmaceutical standards.
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