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    Home > Medical News > Latest Medical News > The limit of adjuvant is coming! Is there time for self-help of traditional Chinese medicine injection?

    The limit of adjuvant is coming! Is there time for self-help of traditional Chinese medicine injection?

    • Last Update: 2019-04-23
    • Source: Internet
    • Author: User
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    In February 2019, the focus interview on the news reported on the catalogue of auxiliary drugs was regarded by the industry as the early warming up of the national edition of the catalogue of auxiliary drugs In 2019, the State Council issued the opinions on strengthening the performance evaluation of three-level public hospitals, including auxiliary drugs in the evaluation indicators In addition, the notice on soliciting the work of drug use monitoring and clinical comprehensive evaluation (letter of solicitation) mentioned that no less than 1500 public hospitals should be selected for comprehensive monitoring of rational use of drugs, and the monitoring of actual use of auxiliary drugs may enter the process management stage Traditional Chinese medicine injection, as a unique product in China, is often regarded as a frequent customer in the catalogue of "auxiliary drugs" The restrictions in 2017 are mainly limited to the use of secondary and above medical institutions In April 2019, Sichuan Province's notice on Seeking Opinions on the implementation of improving the national basic drug system (Draft for comments) mentioned that drugs in the basic drug catalog should not be included in the key monitoring catalog of auxiliary drugs in principle, which means that Chinese medicine injections in the base drug catalog may be exempted from entering the base drug catalog The traditional Chinese medicine injections in the new version of the basic medicine catalogue in 2018 include: Chaihu Injection (2ml), Shenmai injection (10ml, 20ml, 50ml, 100ml), Shengmai Injection (10ml, 20ml), Qingkailing Injection (2ml, 10ml), Xueshuantong injection (2ml: 70mg, 5ml: 175mg), Xueshuantong injection (freeze-dried) (100mg, 150mg, 250mg) Xuesaitong Injection (2ml: 100mg, 5ml: 250mg, 10ml: 250mg) Xuesaitong Injection (freeze-dried) (100mg, 200mg, 400mg) Danshen injection (2ml, 10ml) Mailuoning injection (10ml) in fact, there are not many products of traditional Chinese medicine injection into the basic drug catalog Self rescue of traditional Chinese medicine injection: the announcement of the General Administration of reevaluation and Research on Soliciting Opinions on relevant policies on encouraging innovation and implementation of full life cycle management of pharmaceutical and medical devices (Draft for comments) (No 54, 2017) mentioned "reevaluation of listed injection" According to the relevant provisions of the drug administration law, it is necessary to reevaluate the safety, effectiveness and quality controllability of the approved injection according to the scientific progress of the injection drugs The production enterprise shall conduct comprehensive analysis on the research situation at the time of approval for listing and follow-up research after listing, carry out product composition, mechanism of action and clinical trial research, and evaluate its safety, effectiveness and quality controllability " However, this policy is mainly aimed at chemical injection, not traditional Chinese medicine injection Many enterprises consider self-help through clinical effectiveness test after Chinese medicine injection enters the catalogue of auxiliary drugs, including multi center clinical and real world research According to the roadside news agency, a Provincial Bureau at the meeting said that it was a waste of money to make more traditional Chinese medicine injections In the list of online auxiliary drugs, natural drug injection has always been a frequent customer In this paper, we selected 35 kinds of traditional Chinese medicine injections which are often listed in the list and found that 15 of them have not been found in clinical research and test data, which are safflower yellow pigment, Xingnaojing, Shuxuetong, Gualou PI, Shenqi Fuzheng, Shenkang, gugua extract, Danshen Ligustrazine, Ginkgo biloba leaf extract, Brucea javanica oil emulsion, lentinan, Shengmai, Lugua polypeptide, Rhodiola grandiflora and Shenxiong grape Sugar Clinical studies of Xiyanping, Xuesaitong, Tanreqing, Kangai, Guhong, Aidi, xiaochanping and Reduning have been started before 2017, but no new clinical studies have been started in 2017 However, even if the project is completed, the current auxiliary drugs are determined according to the sales ranking, not according to whether the traditional Chinese medicine injection is judged according to the indication treatment Even if the test data is good, it is difficult to change the fate of the product entering the auxiliary drugs catalogue The clinical research of 35 kinds of natural drug injections in the list of auxiliary drugs since 2017 is as follows: there are two ways for traditional Chinese medicine enterprises to adhere to the research and development of traditional Chinese medicine Classical ancient formula: there is no declaration of "material standard of classical famous formula" On April 13, 2018, the State Administration of traditional Chinese Medicine issued the catalogue of ancient classic prescriptions (the first batch), and in June 2018, the State Drug Administration issued the notice on the simplified registration and approval management provisions of ancient classic prescriptions of traditional Chinese medicine compound preparations (No 27, 2018) The development of the classic prescriptions of traditional Chinese medicine preparation is divided into two stages: the development of the material standard of classic prescriptions and the development of preparations The applicant shall develop the "classic formula material standard" according to the prescription and preparation method published in the ancient classic formula catalogue, and carry out the research on the classic formula preparation according to the "classic formula material standard", to prove that the key quality attributes of the classic formula preparation are consistent with the key quality attributes determined by the "classic formula material standard" "Material standard of classical famous Prescriptions" refers to the standard of traditional Chinese medicine medicinal materials prepared on the basis of the preparation method of ancient classical famous prescriptions recorded in ancient medical books Except for the molding process, the other preparation methods should be basically consistent with those recorded in ancient medical books Within 5 days after receiving the relevant information of "classic famous party material standard" submitted by the first applicant, the drug evaluation institution of SDA shall publicize the list of applicants on its website for 6 months During the publicity period, other applicants can continue to submit the relevant materials of the "classic famous party material standard" developed by themselves through the listing application process, and the applicant's name is single and publicized On March 29, 2019, the comprehensive Department of the State Food and Drug Administration (SFDA) publicly solicited opinions on the requirements for the application materials of the ancient classical and famous traditional Chinese medicine compound preparations and their material Benchmarks (Draft for comments) This means that at present, the material standard of classical prescription has not been formally declared, and no manufacturer can enter the stage of the development of traditional Chinese medicine compound preparation New drugs of traditional Chinese medicine: the number of new drugs approved is less On October 7, 2017, the general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of medical devices of drugs, which mentioned the establishment and improvement of the registration management system and technical evaluation system in line with the characteristics of traditional Chinese medicine, and the handling of the relationship between maintaining the traditional advantages of traditional Chinese medicine and the requirements of modern drug research and development It is worth noting that in the future, the application for registration of traditional Chinese medicine needs to submit the listing value and resource evaluation materials, highlighting the clinical value orientation and promoting the sustainable use of resources The clinical guidelines for new Chinese medicine have been promulgated and updated In 2015, the State Food and Drug Administration issued four technical guidelines, including general principles for clinical research of new traditional Chinese medicine, guiding principles for clinical research of new traditional Chinese medicine, guiding principles for clinical research of new traditional Chinese medicine in the treatment of primary osteoporosis, guiding principles for clinical research of new traditional Chinese Medicine in the treatment of stroke, and guiding principles for new traditional Chinese medicine in the treatment of new traditional Chinese medicine Guiding principle of clinical research technology for treatment of malignant tumor In 2016, the guiding principles for clinical trials of new Chinese medicine in the treatment of influenza were promulgated In 2017, the guiding principles of clinical research technology of new Chinese medicine for irritable bowel syndrome, clinical research technology of new Chinese medicine for functional dyspepsia, clinical research technology of new Chinese medicine for cough variant asthma, clinical research technology of new Chinese medicine for rheumatoid arthritis and chronic heart disease were released Guiding principles for clinical research technology of power failure The above directions are all directions in which traditional Chinese medicine can play its role In recent two years, the approval of new drugs is mainly oral drugs, especially oral liquid and granules, but the number of approved drugs is not very large For example, in 2018, four new Chinese medicine drugs were approved, including two gynecological products, one rheumatoid arthritis product and one cold product Summary: Traditional Chinese medicine is a unique product in China The reason for entering the catalogue of auxiliary drugs is that its ingredients are complex, difficult to quantify, and its effectiveness and safety are not clear Since 2017, many enterprises have also actively carried out clinical research and self-help However, after self-help, can enterprises break away from the "label" of "auxiliary drugs"? This may be to have a clear definition of adjuvant, and an objective third party to give professional judgment Most of the time, the reason why traditional Chinese medicine is attacked is that the ingredients are not single and the quality cannot be controlled If traditional Chinese medicine is regarded as a small molecule with similar structure and the content is not high, and the low content can reduce the side effects, but at the same time, the curative effect is effective, traditional Chinese medicine has the therapeutic value, but it needs to be supported by pharmaceutical research and clinical data The road of self-help of traditional Chinese medicine injections is long but true If you walk out of one path, you will be the king of the "leftovers".
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