Medical network - April 28 to encourage new drugs of traditional Chinese medicine (TCM), CDE (center of total bureau of national food and drug supervision and administration of drug approval) released on April 13, the drugs used for irritable bowel syndrome of traditional Chinese medicine clinical research technical guiding principles "for functional dyspepsia clinical research of new drug of TCM technical guiding principles for cough variant asthma of new drug of TCM clinical research technical guiding principles for rheumatoid arthritis (ra) of new drug of TCM clinical research technical guiding principles" for chronic heart failure in clinical research of new drug of TCM technical guiding principles and TCM drugs for clinical study of dementia technical guiding principles and six guiding principles of the draft. 

 

From the indications, the indications that this batch of guiding principles are chosen are exactly the direction that traditional Chinese medicine can take advantage of. 

 

Positive -- no longer restricted to "disease care" 

 

And released in December 2011, the Chinese medicine, natural medicine treatment of coronary heart disease angina pectoris clinical research technical guiding principles and the Chinese traditional medicine, natural medicine treatment of female climacteric syndrome clinical research technical guiding principles, released in October 2014 and the treatment of malignant tumor of new drug of TCM clinical research guidelines (draft) ", compared to the usual Chinese medicine clinical research guiding principles on the name of "traditional Chinese medicine (drug) in treatment of XXX disease clinical research technical guidelines". In order to avoid the standard western medicine of curative effect, the guideline of the guiding principle is to be adjusted as "the clinical research and technical guiding principle of Chinese traditional medicine for XXX disease". This means that Chinese traditional medicine new drug clinical research is no longer confined to clinical orientation on "treatment", but a more diversified clinical value, such as the quality of life improved or prevent disease. 

 

The guiding principle for new drugs, but also indicate the direction to the faces of Chinese medicine to evaluate products: if the traditional Chinese medicine as a treatment drug, as Chinese traditional medicine, biological products and medicines should be an evaluation criterion, the composition is not single, quality control of traditional Chinese medicine might be disadvantage; However, there is no future for traditional Chinese medicine, which is clearly defined and contained in a single and controlled quality. CDE mentioned, want to innovation of Chinese medicine, can be the first to highlight the characteristics of TCM clinical advantage or therapeutic areas, foster strengths and circumvent weaknesses, clinical value oriented development of new drugs. 

 

Air - clinical orientation is dependent on ancillary dependency 

 

The clinical orientation identified by the present guidelines is based on the therapeutic objective of western medicine and the diagnosis and diagnosis of the disease in Chinese medicine. As shown in table 1, compared with the previous guidelines more focus on the "treatment", this batch of new guidelines to establish three aspects - disease prevention, control and improve the conditions, and the improvement of symptoms. 

 

 

 

Disease prevention and control of diseases and improve the status in clinical medication, symptoms improve the three aspects, are difficult to calculate the "treatment", and prefer to "adjuvant" subordinate status. Current reimbursement of medical insurance reimbursement, the hospital clinical medicine to monitor the medicine, "auxiliary medicine" is the object that is the key observation. If the Chinese medicine goes into these three areas, there will be a problem of clinical use. However, the three aspects are the research and development of Chinese medicine by CDE. In the case of companies, the development of new drugs will continue to be "frozen" if input is not rewarded. 

 

In the end, Chinese and western medicine are two different systems, and from table 2, the diagnostic criteria of TCM are more qualitative than quantitative. In view of this, the Chinese herbal medicine new medicine clinical research technical guidelines for cough variant asthma (draft) "proposed" the curative effect of TCM syndrome evaluation, consider using primary symptom of TCM + time integral value calculation. The syndrome curative effect judgment standard of integral value degree: clinical control: 95% or higher, powerfully: 70% or higher, effective 30% or higher, invalid: less than 30% ". Therefore, the guiding principle is also promoting the quantization of clinical indicators in TCM. 

 

PK - good or bad? 

 

CDE has given two routes to Chinese medicine companies. 

 

One route is "simple mode". Enterprises can to disease prevention, control and improve the conditions, and the symptoms improved three aspects to research and development, and then to evaluate the effect of product, the corresponding get is "adjuvant" subordinate status, limited coverage, the size of the market is limited. 

 

The other was a "difficult to model", the product "treatment" direction development, Chinese medicine, chemical medicine and biological agents in the same starting line, not biased Chinese traditional medicine. Traditional Chinese medicine (TCM) want to get the status of the "treatment", it will be to develop in the direction of natural medicine chemistry, looking for ingredients is relatively single, curative effect is reliable, stable, components of traditional Chinese medicine monomer, step by step, and medicine. The "difficult mode" is long and risky, and the rewards will be similar to one of the new drugs that are already listed in the country. 

 

For small and medium enterprises, the short term in order to survive and sustainable development, can consider the first route layout, especially at present no cure and severe lack of clinical disease field of new drugs. In the case of large group companies, such as the pharmaceutical industry, which have developed and listed the successful experience of Chinese traditional Chinese medicine, the "difficult mode" could be considered. 

 

Launched in 2011 started to guiding principles, from the perspective of the declaration registration response of enterprise, the guidelines issued more like set up the threshold of a research and development, the enterprise only across the threshold is expected to reap the rewards. The benefits and benefits depend on whether companies are giving up or trying to climb.