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    Home > Active Ingredient News > Drugs Articles > In view of the defects such as unclear drug content and unknown side effects, the State Food and Drug Administration issued guiding principles

    In view of the defects such as unclear drug content and unknown side effects, the State Food and Drug Administration issued guiding principles

    • Last Update: 2018-02-06
    • Source: Internet
    • Author: User
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    Source: on February 6, 2018, people's daily, the core reading specifications are not closely related to the usage and dosage, the adverse reactions are not clear, and the core elements are not fully marked The information in many Chinese patent medicine instructions is not standard and complete, which causes confusion to patients and doctors In this regard, the State Food and Drug Administration issued guiding principles to standardize the instructions of Chinese patent medicines, so that the use of drugs is clear at a glance The guiding principles encourage enterprises to promote the standardization in a planned and independent way according to their own conditions, so as to promote the high-quality development of the traditional Chinese medicine industry In winter, there is a lot of flu Ms Li, from Chaoyang District, Beijing, has the symptoms of stuffy nose, runny nose, cough and headache She went to the drugstore and bought a box of Lianhua Qingwen granules Carefully read the instructions: "specification" is 6G per bag; "usage and dosage" is oral, one bag at a time, three times a day Although how to use the medicine is very clear, but how many drugs are used, will there be side effects that make people confused The drug is marked with more than ten main ingredients, such as honeysuckle and Rhodiola, but the drug content per gram is not indicated At the same time, the "adverse reactions" and "Taboos" in the manual are "not clear", and only "precautions" indicate that the athletes should be cautious Ms Li is confused after seeing it Athletes can't use it Can pregnant women use it? In fact, it is quite common that the information in the manual of traditional Chinese medicine is not standardized and complete The State Food and Drug Administration recently issued the technical guidelines for specification presentation of Chinese patent medicines (hereinafter referred to as the "principles"), will it help to standardize the specifications of Chinese patent medicines? What about making the medication more clear and reassuring? It is convenient to use medicine The manual should be revised dynamically "Chinese patent medicine makes Chinese herbal pieces into a certain dosage form, which is convenient for patients without decocting Many Chinese patent medicines are over-the-counter drugs (OTC) Patients can go to the drugstore to purchase and use them directly But when I read the manual of traditional Chinese medicine, it was just a few hundred words, and some items related to drug safety were written as "unclear" and "unknown" Such instructions are not only inconvenient for patients to use drugs, but also bring hidden dangers to drug safety At the same time, pharmacists should guide patients to use drugs, and need to check relevant literature and technical standards to find out whether these drugs can be used for pregnant women, children, the elderly and other special groups " Zhang Xiaole, head of the expert group on drug safety of the Hospital Pharmacy Committee of the Chinese Pharmaceutical Association and former deputy director of the pharmacy department of Peking University Third Hospital, said "The regulatory policies are all based on people as the core, in order to ensure the drug safety of the people The purpose of standardizing the specifications of Chinese patent medicine is to make it clear to doctors and patients at a glance " Food and Drug Administration of the drug and cosmetics registration department of the relevant responsible person said For example, some Chinese patent medicine specifications are not closely related to usage and dosage The specification of a document number is 60g per bottle, and the dosage is 20 pills per time The doctor or patient does not know how much weight each 20 pills is and how many pieces they contain If the specification is changed to 0.15g per pill, the doctor or patient will be more clear in medication For another example, the prescription in some document number drug standards is compound, but the specification only indicates the content of single drug ingredients, which is not comprehensive and easy to mislead For example, the compound berberine tablet (sugar coated tablet) is composed of berberine hydrochloride, Muxiang, Evodia rutaecarpa, paeony, etc., but the specification only indicates that each tablet contains 30 mg berberine hydrochloride, without the dosage of other pieces in the compound, and the core elements are not fully labeled Of course, the specification of Chinese patent medicine is not only one of the problems, but also the lack of "adverse reactions", "Taboos" and "precautions", which has certain hidden dangers It is understood that when a doctor uses a Chinese patent medicine, there is no indication of any ingredients and contents in the manual, and there is no warning text As a result, excessive use of the medicine will cause harm to the patient According to the person in charge of the registration and Management Department of drugs and cosmetics of the State Food and drug administration, many products have been on the market for many years If adverse reactions are detected after they are on the market, they must be fully explained when modifying the instructions After the establishment of the drug listing license holder system, the drug listing license holder is mainly responsible for the safety, effectiveness and quality controllability of the drug The national ADR monitoring center will also feed back information to enterprises through relevant channels every year, and the revision of drug instructions in the future should be dynamic It is encouraged to be voluntary and will not be "one size fits all" for the description and statistics of 60194 TCM preparation number specifications by the research group of Shanghai University of traditional Chinese medicine in a short period of time Nearly 90% of TCM number specifications do not indicate the drug content of single dose of drugs under the "specifications" of the instructions, but indicate the specifications by weight, loading, etc Taking Lianhuaqingwen granules as an example, according to the principles, its specification should be expressed as "every 1g is equivalent to ×× g of decoction pieces" Some media interpret the principles as that at least 90% of Chinese patent medicines need to modify the instructions to give people a "one size fits all" feeling In response, the relevant person in charge of the drug and cosmetic registration and Management Department of the State Food and Drug Administration said: "the specification description of Lianhua Qingwen granules really needs to be improved in the future, but considering the cost of the enterprise, the regulatory authorities will not enforce the specification at present, and encourage the enterprise to regulate in a planned and independent way according to its own situation Companies don't have to worry about the sale of current products, and the public can guarantee safety by using drugs under the guidance of pharmacists " Different from the two-year transition period set in the previously issued technical guidelines for generic names of Chinese patent medicines, there is no mandatory implementation schedule for the principles It mainly encourages enterprises to voluntarily regulate themselves, instead of "one size fits all" in the short term However, if the enterprises are unwilling to regulate consciously for several years, the regulatory authorities will form a situation of backwardness through measures such as the implementation of the responsibilities of drug listing license holders and drug re registration "It is a good sign to standardize the technical standards of Chinese patent medicine specifications, which shows that the regulatory authorities attach importance to the standardization of Chinese patent medicine specifications, and actively promote the development of Chinese patent medicine management in the direction of scientific standardization Traditional Chinese medicine, like western medicine (chemical medicine), has two sides While curing the disease and saving people, it also has its adverse reactions It is required to standardize the drug Manual of Chinese patent medicine from a scientific point of view, and its standard should not be lower than that of Western medicine " Zhang Xiaole said Based on a long-term perspective, standardization forces enterprises to develop traditional Chinese medicine, which is a national treasure and also related to the life and health of the people Therefore, the relevant policies issued by the regulatory authorities are naturally of great concern In the near future, the regulatory authorities have been accelerating the pace of introducing relevant policies in the field of Chinese patent medicine Combing the regulatory policies in the field of Chinese patent medicine will find a key word - standardization Standardization will force the high-quality development of traditional Chinese medicine Standardization is not to control the traditional Chinese medicine industry, but to make the industry develop better Standardization is an important measure to ensure the quality of products in the modern production of traditional Chinese medicine "Chinese patent medicine manufacturers should also take responsibility In fact, it's relatively easy to standardize specifications, and much work needs to be done to supplement the" adverse reactions "," Taboos "," precautions "and other items Some Chinese patent medicines have been sold in the market for many years Pharmaceutical companies have the responsibility to observe their adverse reactions and try to get the first-hand information to study and improve the instructions, so as to make their products have a longer-term development " Zhang Xiaole told reporters Standardization is also conducive to traditional Chinese medicine to the world In recent years, traditional Chinese medicine has been gradually recognized internationally, especially the development of artemisinin, a Chinese medicine, by Chinese scientists, which won the Nobel Prize in physiology or medicine In order to move towards the international market, first of all, we need to improve our internal skills at home On the basis of respecting the characteristics of traditional Chinese medicine, we must adhere to the management idea that conforms to the drug attributes, so as to make traditional Chinese medicine bigger and stronger, be widely accepted by the stable curative effect, and even lead the international standard "Only when the Chinese patent medicine, like the western medicine, is strictly required to have its specification standard, can the traditional Chinese medicine carry forward and go to the world." Zhang Xiaole said At present, the registration management system in line with the characteristics of traditional Chinese medicine has been initially established, but it still needs to be improved, said the relevant person in charge of the Department of drug and cosmetic registration of the State Food and drug administration In the future, there will be more and more Chinese patent medicines that are more standardized and more convenient for doctors and the public to use.
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