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    Home > Active Ingredient News > Drugs Articles > 9 Chinese medicines applied for IND in FDA and the results of Chinese medicine are popular

    9 Chinese medicines applied for IND in FDA and the results of Chinese medicine are popular

    • Last Update: 2014-03-27
    • Source: Internet
    • Author: User
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    Source: pharmaceutical economic report 2014-03-27 at present, nine Chinese medicine varieties have applied for ind (investigational new drug) in the U.S Food and Drug Administration (FDA), and several varieties have entered the III clinical trial; at the same time, more than 10 evidence-based medicine research of Chinese medicine has been highly recognized internationally This was learned by a reporter of Japan daily on March 23 at the 2014 Nobel Prize winner medical summit and academician forum Chen Zhu, vice chairman of the Standing Committee of the National People's Congress, chairman of the Central Committee of the Democratic Party of agriculture and industry of China and academician of the Chinese Academy of Sciences, said that the realization of the integration of modern medicine and traditional Chinese medicine has become one of the important research fields in China The Chinese medicine industry and Nobel Prize winners hold a grand meeting to show the achievements, which is enough to show that the internationalization of traditional Chinese medicine in China has achieved a step-by-step walk In recent years, the achievements of traditional Chinese medicine have been highly praised The Chinese medicine community has recognized that evidence-based medicine research is an internationally recognized authoritative method to evaluate the efficacy and safety of drugs, and has carried out a number of evidence-based medicine research successively, which has brought the gradual recognition of traditional Chinese medicine in the world and greatly widened the road of internationalization of traditional Chinese medicine Wu Yiling, academician of the Chinese Academy of engineering, said that at present, more than 10 evidence-based medicine researches in the field of traditional Chinese medicine have been highly recognized internationally For example, the Journal of the American Society of Cardiology published evidence-based medicine research results of Qiliqiangxin capsule in the treatment of chronic heart failure; the British Journal of heart disease commented that "Chinese herbal medicine brings new hope for the treatment of heart failure" It is understood that in the past 10 years, traditional Chinese medicine has made remarkable achievements in the process of internationalization The standard of Salvia miltiorrhiza developed by China pharmaceutical company was included in the US pharmacopoeia, and five varieties such as Sanqi were included in the European Pharmacopoeia; Xinxuekang produced by Chengdu Di'ao also completed the registration in the EU In addition, the FDA registration of Chinese patent medicine has also made important progress After the completion of the FDA registration of the compound Danshen dropping pill, the phase II clinical trial of Fuzheng Huayu tablet developed by Shanghai Modern Chinese Medicine Co., Ltd was also highly recognized by the FDA Zhizhikang produced by Beijing Beida Weixin Biotechnology Co., Ltd passed the ind application in 2007, and the phase I exemption directly entered the phase II clinic Phase II clinical trial has been completed in 2013, and phase III clinical trial is also in active preparation The research group, led by Chen Keji, academician of the Chinese Academy of Sciences, pioneered the treatment of coronary heart disease with the method of activating blood circulation and removing stasis of traditional Chinese medicine, prevention and treatment of coronary restenosis and recurrence of angina pectoris after interventional treatment, etc in addition, the research group also developed more than 30 new Chinese medicine for promoting blood circulation and removing stasis of cardio cerebrovascular diseases, of which more than 10 have been approved for clinical application, and some products are preparing to be applied in FDA IND Zhang Boli, academician of the Chinese Academy of engineering and President of the Chinese Academy of traditional Chinese medicine, pointed out that the advantages of traditional Chinese medicine lie in its clinical efficacy However, the clinical efficacy needs to be expressed with scientific data to be recognized by the international community Chinese traditional medicine enterprises have taken the initiative to seek interdisciplinary and transnational cooperation, and have won a certain voice for Chinese traditional medicine in the world From the perspective of the occurrence of global diseases, chronic diseases have become the biggest threat, and traditional Chinese medicine has great advantages in the prevention and treatment of chronic diseases, which is also the best time for traditional Chinese medicine to move towards the international market Chen Keji believes that both scholars in the field of traditional Chinese medicine and traditional Chinese medicine manufacturers should seize this good opportunity Wang Guoqiang, deputy director of the national health and Family Planning Commission and director of the State Administration of traditional Chinese medicine, also said at the meeting that the Chinese government attaches great importance to the development of traditional Chinese medicine as a unique national health resource, a huge potential economic resource, a technological resource with original advantages, an excellent cultural resource and an important ecological resource Chen Zhu pointed out that in the development of medical and health services with Chinese characteristics, the Chinese government has always adhered to the principle of attaching equal importance to both Chinese and Western medicine, placing TCM and Western medicine in the same important position Richard Roberts, the winner of the 1993 Nobel Prize in physiology of medicine, said that traditional Chinese medicine is not only a treasure of China, but also a treasure of the whole human race He hoped to strengthen exchanges and cooperation with scientific and technological workers of traditional Chinese medicine, and work together to promote the development of medical cause and improve human health Zhang Boli believes that if TCM wants to go to the world, it must make full use of modern science and technology on the basis of TCM theory, absorb modern science and technology methods, use modern research methods, dosage forms and language expressions, and let Westerners understand and accept it At the meeting, Chen Zhu put forward three requirements for "how to realize the integration development of modern medicine and traditional Chinese medicine": first, give full play to the respective advantages of traditional Chinese and Western medicine, cooperate with each other and complement each other; second, identify the entry point for the integration development of modern medicine and traditional Chinese medicine; third, strengthen the communication and cooperation in the field of traditional Chinese and Western medicine.
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