Representatives are looking forward to re-evaluation standards for Chinese medicine injection

Pharmaceutical Network March 5 hearing 2018 two sessions about to be opened, the medical and health representatives, members of the proposal, the motion concerned about the topic? Xiaobian take you into the 'two sessions of the channel.'

With the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the "Circular on Deepening the Reform and Examination and Approval System Reform Encouragement drug medical instruments Innovative opinions, "the competent national authorities once again start the re-evaluation of traditional Chinese medicine injection of research work.After experiencing the" 7.22 clinical trial data verification of the storm "chemical consistency assessment action ' medicine Industry "transformation and upgrading, help optimize the inferior" vast project is being kicked off.

Reporter recently learned that, after more than 70 years of development, China's traditional Chinese medicine injection products enterprise There are 302, Chinese medicine injection of 132 varieties, the industry scale of 90 billion yuan in the past three years, the total output of more than 100 million pieces of 7 varieties, the output of 10 million to 100 million pieces of varieties between raw veins Injection, Xuesaitong injection and other 41 varieties.

So, in the re-evaluation of traditional Chinese medicine injection started, what species need to complete the re-evaluation as soon as possible?

Sun Xiaobo, director of the Chinese Academy of Medical Sciences Institute of Medicinal Plants, said: 'First, the further application of injections must meet the clinical needs of unsatisfied, and more used in critical, severe and acute diseases, in order to obtain other drug formulations Can not achieve the effect of one of the necessary measures taken; Second, from the product sales point of view, the sales of more than 100 million yuan varieties need to re-evaluate as soon as possible, although the sales does not explain the quality of the varieties of good and bad, but the Hundreds of millions of dollars must have clinical needs.

The latest data show that there are currently 132 Chinese traditional medicine injection varieties in China, of which 129 are national drug standards and 3 are enterprise registration standards, of which 5 are included in the 2015 edition of the Chinese Pharmacopoeia, There are 53 standard varieties, 29 landmark varieties and 20 new drug standards (including 9 new drug positive standards and 11 new drug standards), and 29 of the revised and revised standards are issued.

NPC deputy and Chinese Academy of Engineering, said Zhang Burley, Chinese medicine injection is the modernization of traditional Chinese medicine results in the clinical diagnosis and treatment process has played a key role, can effectively replace some antibiotics, especially in the treatment of viral diseases with significant results.In addition, Traditional Chinese medicine injection also changed the traditional Chinese medicine administration, its rapid effect, high bioavailability, in the treatment of acute critical illness has played an important role.

Zhang Baili pointed out that 'the quality control of Chinese medicine injection approved in recent years has been very strict control, but in the past due to the relatively limited level of technology, there seems to be a lot of deficiencies now, we need to re-study the previous varieties according to the current standards, including Re - confirm the quality, standard and technology of the varieties, at the same time, carry out clinical safety evaluation and clinical efficacy evaluation, these are the lessons that Chinese medicine injection must make up in the development.

Recently, in a reporter's interview, many delegates also expressed the urgent hope that the re-evaluation criteria of Chinese medicine injection can be released as soon as possible, so many companies can conduct self-evaluation. If you think these varieties are over-used in the course of their use, most enterprises will themselves Take the initiative to request delisting.This will not only solve the hidden dangers of injections in clinical use, but also allow a lot of quality varieties to be further improved.

Zhang Baili pointed out that the property of the drug is to prevent and cure diseases. To prove the effectiveness, traditional Chinese medicine injections, like other drugs, need basic research and clinical research. What matters is the quality of evidence and the evidence is in chain. This requires clear clinical positioning, Scientific and reasonable design, strict data management and credible research conclusion.To correctly understand the rational use of traditional Chinese medicine injections, research should be strengthened to improve the safety, effectiveness and quality control of traditional Chinese medicine injections, neither to kill innocent people nor allow them to be mistaken Pass.

'Chinese medicine injection is different from the chemical composition of the western medicine is relatively clear, the mechanism of action and role of the site clear, complex chemical composition of traditional Chinese medicine, basic research is weak, the active ingredient is often not clear. "Sun Xiaobo that Chinese medicine is made after injection, Can not play a leading role and the mode of action is also different from the traditional Chinese medicine preparations, so the positioning of traditional Chinese medicine injection should belong to the innovation of Chinese medicine for injection, its safety, effectiveness evaluation should follow the special requirements of innovative drugs, but to take into account Chinese medicine specialty.

Data show that China's traditional Chinese medicine injections market concentration is higher.Cement 10 cumulative proportion of about 45%; the first 20 kinds of products cumulative weight about 70% .In the top 20 varieties of 11 cardiovascular and cerebrovascular medicine injection 7 cardiovascular injections and 4 cerebrovascular injections), 6 were anti-tumor injections, and the remaining 3 were detoxification and detoxification injections.7 of the top 10 varieties were cardio-cerebral-vascular injections (5 cardiovascular injections, 2 brains Vascular injection), two for the anti-tumor injection, one for the Qingrejiedu injection.

This reporter learned that, in fact, in the clinical diagnosis and treatment process, more than 90% of physicians treated with traditional Chinese medicine injections are Western medicine. Physicians who have the theoretical basis of western medicine diagnosis and treatment can not distinguish the symptoms of traditional Chinese medicine and can not accurately and properly use traditional Chinese medicine injections. Reasonable application of the hidden dangers.Chinese medicine, natural medicine injection route of administration is different from the traditional dosage form.In most cases, the traditional experience of the pharmaceutical composition of injection prescription compatibility and the proportion of guidance is limited.

Chen Keji, member of the Seventh, Eighth and Ninth CPPCC National Committee members and Chinese Academy of Sciences, pointed out: 'The route of administration for injection must be the choice of dosage form when other non-injectable routes of administration such as oral administration can not effectively play its role. In addition to the principle of evaluating the effectiveness of new drugs in general, they should also meet the advantages of the administration route, the advantages of functional indications or the superiority of the group.

Zhang Shichen, former director of the registration department of the State Food and Drug Administration, said: 'Based on the current status of TCM research and the particularity of traditional Chinese medicine injections, in the evaluation system of the effectiveness of Chinese traditional medicine injections, especially in combination with conditions Under the framework of the research, if the mode of efficacy based on TCM syndromes is adopted, in fact the support for its effectiveness will be very limited.

Sun Xiaobo believes that 'First, to strengthen the top-level design, step by step, block, phase implementation; second, to strengthen existing clinical applications, literature research, the formation of clinical and related basic research from the big data, bioinformatics, network Third, to strengthen basic research, to provide a basis for the formation of optimized clinical programs based on the characteristics of the drug being evaluated; Fourth, to strengthen the optimization of clinical research programs to form a combination of 'disease-syndrome' , Modern disease elements as the main indicator of the research program, a true and objective evaluation of its effectiveness, for a wider range of applications provide a complete and systematic evidence chain, lay a solid foundation to highlight the value.

CPPCC member, academician of Chinese Academy of Engineering Huang Luqi also said in an interview with this reporter: 'Chinese medicine injection was born in the 40s of last century, can be regarded as a revolutionary innovation in the development of Chinese medicine .At present, the traditional Chinese medicine injections Safety concerns, or the formation of public opinion whirlpool, become the focus of public concern and supervision of competent authorities, urgently need to actively guide the transformation and upgrading of Chinese medicine injection industry.