For examination and approval of TCM injections to drug firms abandon r&d experts: should be fair 
 
 
March 26, 2014 
 
 
Source: People's Daily online 

        "TCM variety received 707, while Chinese medicine injection is only four." This is the state food and drug supervision and management of administration (CFDA) provided by the statistical data in 2013.
        The data seem to confirm the personage inside course of study to the concerns of the tougher for examination and approval of TCM injections. Even some enterprises for fear of examination and approval of TCM risk and give up when we do research and development of TCM injections.
        Why TCM injections to suffer numerous criticism? Is it true that the current situation as the surface increased the difficulty of the traditional Chinese medicine injection industry development? Traditional Chinese medicine (TCM) injections will be how to develop? "Proceedings in China" reporter visited a number of experts, trying to parse the traditional Chinese medicine injection development facing the opportunities and challenges.
        Should be treated with justice
        TCM injections are seen as an extension of the traditional Chinese medicine (TCM) modernization, it has changed the traditional Chinese medicine oral dosing way, make up for the traditional Chinese medicine oral or other ways to get effective slow shortcomings, but at the same time also brought a lot of adverse effects, and even endanger the safety of life.
        According to the report of CFDA adverse reactions, traditional Chinese medicine adverse reaction about 75% are caused by traditional Chinese medicine injections, proprietary Chinese medicine adverse reaction reports the number of the top 20 varieties of traditional Chinese medicine injection.
        This data, the state administration of traditional Chinese medicine of jiangsu province academy of traditional Chinese medicine, Chinese medicine drug release system key research director Jia Xiaobin believes that traditional Chinese medicine injection adverse reaction is mainly from three aspects.
        First of all, insufficient injection dosage forms of technology. Injection process for sterilization, such as potting process is unqualified, lead to the generation of heat source and so on, cause adverse reactions; Second, traditional Chinese medicine injection production complex, involving medicinal herbs cultivation, processing, extraction, intermediates and finished products, and other steps. These processes are likely to be brought into resin, heavy metal, harmful material such as protein, tannic acid, that cause adverse reactions.
        "Moreover, the side effects of active ingredients or components is also another reason for adverse reaction occurred. Ingredients or components can only play a role in certain dose scope, over dosage can cause side effects." Jia Xiaobin added.
Although TCM injections for the above reason of skepticism, but now almost every hospital in the clinical use of TCM injections, higher market share gradually. Such as ginkgo biloba injection, Dan red injection, blood clots injection and Kang Yi ejaculation, salvia miltiorrhiza injection, etc., covering almost all 3 armour hospital in China.
        "Traditional Chinese medicine injection is the innovation of the traditional Chinese medicine, we should not be one-sided view of the traditional Chinese medicine injections, but should be objective and correct understanding of the curative effect of TCM injections and defects." Jia Xiaobin said. 
        Before China's traditional Chinese medicine association FangShuTing in an interview with "Chinese proceedings" reporters repeatedly said: "any drug adverse reactions, if because of adverse reactions is a policy of radical cancellation of the traditional Chinese medicine injection, it was isolate."
        In fact, with the GMP production of strict management implementation, TCM injections for dosage form process cause adverse reactions has obtained the better control. But in recent years such as ShuangHuangLian injection, herba houttuyniae TCM injections reported adverse events, the safety of TCM injections again cause all aspects of the concern and attention. State food and drug supervision and management of administration is to formulate the TCM injections safety evaluation, assessment of production technology, and again seven technical principles.
        "That the research and development, the clinical application of TCM injections in the specification, will pull the TCM injections into the track of healthy development." Jia Xiaobin thinks, attaches great importance to in injection drug safety and attention today, traditional Chinese medicine (TCM) injections with the innovation of manufacturing process should be treated by "justice" - should not only see the security flaws, and to improve the quality standard and strengthening quality control.
        Strict examination and approval and to evaluate power industrial upgrading
        Expectations of treatment of traditional Chinese medicine injection by "justice" and chengdu hundred abundant technology pharmaceutical co., LTD., vice President of ya. He told reporters, the proceedings of the People's Republic of China. Due to the national policy uncertainty about TCM injections, risk is bigger, for Chinese medicine injection technical requirements are still unclear, combined with traditional Chinese medicine injection quality control and clinical trials are still need to constantly improve and perfect, which directly lead to the society of traditional Chinese medicine (TCM) injections is full of confusion and hesitation.
        However, experts also said that the both test and opportunities for the development of TCM injections. TCM injections and evaluation will be in strict accordance with the "traditional Chinese medicine and natural medicine injection basic technical requirements" and "TCM injections safety evaluation work plan again" and other relevant requirements, approval threshold will gradually improve, will push Chinese medicine injection industry upgrade.
        Ya, only the use of advanced production technology, strict quality control indicators, ensure the quality of drug batch between uniform stability, a clear product material basis and mechanism of to ensure the efficacy and safety of clinical medication. So she generously for two sessions on behalf of the propulsion has listed the safety of the varieties of traditional Chinese medicine injection clinical evaluation proposal again.
        "The technology level of the domestic pharmaceutical industry is developing very fast, new technology, new equipment, new methods constantly emerging, traditional Chinese medicine production enterprises should be through the professional design, improve product quality level, in a planned way to accelerate the upgrading of products, ensure the safety of clinical drug use. As a traditional Chinese medicine injection manufacturers, the main responsibility and actively cooperate with the country's regulatory requirements, review the initiative and adverse drug reactions monitoring in the process of clinical use." Ya said.
        According to related statistics, in addition to a few varieties is approved after 2000, the existing clinical use of TCM injections by more than eighty percent is older drugs, which is implemented in 1985 the local approval of new drugs and new measures for examination and approval before. For these drugs, although improved testing standards, but still stay in the past, the production process failed to keep pace with The Times, the use of the decades has many deficiencies were exposed gradually.
        So Jia Xiaobin think: "if you don't raise improvement directly for clinical safety evaluation, the evaluation effect is limited. Again need according to the clinical demand, according to the nature of the drug, make reasonable and scientific production process, improve the quality standards of TCM injections, improve product quality, and then safety evaluation. This will greatly promote the development of TCM injections, promote industrial upgrading of TCM injections."
        The future research direction
        Although the road to the development of TCM injections are full of twists and turns, but in an interview with a number of experts are still full of expectation to its, agree through industrial upgrading, truly achieve the material basis for the efficacy material base and safety related clear mechanisms, stable structure, base, scientific and reasonable production process, clear and reasonable quality standards controlled biopharmaceutical properties, traditional Chinese medicine (TCM) injections will reach a new level.
Ya is expected, the further research of plant medicine effective component and the safety evaluation is still a research hot spot. "At home and abroad have been listed and paclitaxel injection (active ingredients extracted from plant taxus chinensis) has proven its effectiveness and safety control."
        So, how will the future TCM injections? Jia Xiaobin thinks that traditional Chinese medicine injection components should clarify material basis and studying the structure characteristics, also want to focus on the material basis of security-related features study on characteristics and dosage form of quality control, in addition, also need to process and multi-level dynamic quality control. Because the drug is produced instead of the inspection, so the production process is important to the whole process of dynamic quality control.
Finally, Jia Xiaobin stressed: solve the efficacy and safety of the relevant material foundation, make scientific and reasonable production process, improve the quality standard and realize the whole process from raw material to product of multilevel dynamic quality control, strengthen the adverse drug reactions monitoring, etc., to improve the efficacy and safety, reduce the incidence of adverse reactions, the purpose of product quality control, stability, the realization of TCM injections again evaluation work, it is of great significance to the development of TCM injections.