Drug examination center held a retreat on guiding principles for clinical research of new Chinese Medicine

Source: CDE 2017-05-24 in order to speed up the establishment of the technical standard system of traditional Chinese medicine in line with the characteristics of traditional Chinese medicine and promote the scientific and orderly research and development of new traditional Chinese medicine, the drug evaluation center of the State Food and Drug Administration held a retreat on the technical guidelines for clinical Research of new traditional Chinese medicine on May 17, 2017 At the meeting, relevant academicians and authoritative experts were invited to participate in the meeting to discuss issues related to the preparation and revision of technical guidelines for clinical research of new Chinese medicine Zhou Siyuan, deputy director of drug Audit Center, attended the meeting, and Wu Yiling, President of Hebei Institute of integrated traditional Chinese and Western medicine and chairman of Yiling Pharmaceutical Group, presided over the meeting Zhou Siyuan pointed out that in recent years, the state attaches great importance to the work of traditional Chinese medicine With the promotion of the reform of the drug review and approval system, the General Administration has successively issued several opinions on the review of traditional Chinese medicine The drug review center has actively implemented various measures, played the role of the baton of drug technical review, and carried out the top-level design of the technical guidance and standard system in line with the characteristics of traditional Chinese medicine However, the formulation of guiding principles of traditional Chinese medicine still faces some difficulties and challenges For example, most guiding principles of traditional Chinese medicine need our own original thinking, rather than the guiding principles of biochemical medicine can learn from the relevant technical requirements of foreign countries He pointed out that the drug audit center should adhere to an open mind, constantly strengthen cooperation and communication with the industry, build consensus, lay a good foundation for the top-level design of the next step of the guiding principles, so as to promote the research and development innovation of new Chinese medicine Tang Jianyuan, the head of Clinical Department of traditional Chinese medicine in the center for drug review, introduced the recent work on the preparation and revision of technical guidelines for clinical research of new traditional Chinese medicine from the aspects of background and objectives, process and results, compilation theme and characteristics He pointed out that first, the transformation of clinical guiding principles of traditional Chinese medicine should highlight the advantages and characteristics of clinical treatment of traditional Chinese medicine The second is to broaden the clinical research path of new Chinese medicine Third, the revision of guiding principles needs to further integrate social resources and achieve normalization Fourth, the formulation and revision of the guiding principles need to be further open to the community and more open and transparent Experts at the meeting pointed out that the preparation and revision of clinical guidelines for new drugs of traditional Chinese medicine in the drug examination center emphasized the characteristics of traditional Chinese medicine and the dominant diseases of traditional Chinese medicine, which was conducive to giving full play to the clinical advantages of traditional Chinese medicine and promoting the R & D and innovation of new drugs of traditional Chinese medicine Experts suggest that, first, the guiding principles of new Chinese medicine should be formulated comprehensively and in a timely manner; second, the drafting of guiding principles should ensure its authority, timeliness, sustainability and inclusiveness; third, the path should be widened, space should be set aside, the development of multiple values of traditional Chinese Medicine should be encouraged, the clinical advantages of traditional Chinese medicine should be highlighted, and the clinical needs should be met Fourth, the drafting of guiding principles of traditional Chinese medicine should be closely combined with the actual research and development of traditional Chinese medicine Fifthly, we should speed up the comprehensive sorting out of the old guiding principles to lay the foundation for the formulation and revision of the new guiding principles Professor Tang Xudong, President of Xiyuan Hospital Affiliated to the Chinese Academy of Sciences, Professor Liu Qingquan, President of Beijing Municipal Hospital of traditional Chinese medicine, Professor Gao Ying, vice president of Dongzhimen Hospital of Beijing University of traditional Chinese medicine, Professor Liu Zhen, vice president of Guang'anmen Hospital of the Chinese Academy of Sciences, Professor Mao Jingyuan, President of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, and Xie Chunguang, vice president of the Affiliated Hospital of Chengdu University of traditional Chinese Medicine Prof Duan Junguo, Dean of ophthalmic hospital affiliated to Chengdu University of traditional Chinese medicine, Prof Lu Chuanjian, vice president of Guangdong Hospital of traditional Chinese medicine, Prof Xu Jian, Dean of Shanghai Hospital of traditional Chinese medicine, Prof Jiang Jian, vice president of Shuguang Hospital Affiliated to Shanghai University of traditional Chinese medicine, Prof Chen Yugen, vice president of Jiangsu Hospital of traditional Chinese medicine, and personnel from relevant departments of drug audit center attended the meeting.