Medical network on April 17 - April 13, 6 diseases (irritable bowel syndrome, functional dyspepsia, cough variant asthma, rheumatoid arthritis, chronic heart failure, dementia) of traditional Chinese medicine new medicine clinical research technical guidelines on CDE network for advice. 

 

Guiding principles for the drafting explanation, points out that the therapeutic areas involved are based on the traditional Chinese medicine clinical practice of in-depth research and thinking, choose to highlight the characteristics of TCM clinical advantage or to transmute the guiding principles of therapeutic areas. 

 

CDE in drafting notes the change of the idea of working are introduced: 

 

1, the full involvement in research and development of new drug of TCM 

 

CDE encourage Chinese medicine clinical value oriented innovation, truly combining drug evaluation and clinical demand. In the therapeutic areas, even if there is no relevant chemical medicine clinical research guiding principles for reference, but as long as the current clinical practice of traditional Chinese medicine treatment has involved and there are advantages and characteristics of CDE also can consider to be included in the guidelines for transformation. 

 

In addition, for some therapeutic areas more special or relatively complex clinical guidelines, the CDE will be fully involved in this kind of new drug research and development, once the successful listing of drug research, guiding principles will be released. 

 

2, broaden the research path of new drug of TCM 

 

CDE encourage research of new drug of TCM to foster strengths and circumvent weaknesses, prominent characteristics and clinical advantages. Always the name of the guiding principles are "Chinese medicine new medicine clinical research technical guidelines for the treatment of XXX disease", the unified adjust as "for XXX disease clinical research of new drug of TCM technical guidelines". Purpose is to emphasize the diversity of clinical value of new drug of TCM, to further broaden the path to new drugs for traditional Chinese medicine research, set aside innovation space. 

 

Located in disease treatment, for example, the Chinese traditional medicine, biological products and medicines should be a evaluation standard; But if it is located in the quality of life improved, has the development significance and clinical thought and treatment needs, so Chinese medicine can also be from the actual needs of clinical therapy to develop new drugs. 

 

3, normalized guidelines system revision work 

 

The Chinese medicine new medicine clinical research guiding principles for drafting work is by the authority of Chinese and western medicine experts in the field of domestic professional and CDE review of relevant professional senior member participation. Whatever CDE organized by Chinese medicine new medicine clinical research guiding principle in the future will be jointly responsible for the drafting team experts maintenance updates. Once a therapeutic areas appear or discipline development, the advancement of science in the drafting team will follow up and timely revised guidelines at any time, to ensure that the traditional Chinese medicine new medicine clinical research guiding principle is scientific, authoritative and timeliness. 

 

4, the guiding principles for further transparency and revising 

 

CDE in traditional Chinese medicine new medicine clinical research guiding principle and revising process, also will further strengthen the open and transparent. In addition to online advice, in expanding the expert discussion meeting in draft form can even invite the successful research and development enterprise researchers involved in traditional Chinese medicine new medicine clinical research guiding principle of work and revising.