November 6，The official website of the State Drug Administration released the "Principles of the Technical Guidance of stake sports betting appthe New Medicine Research Research on New Chinese Medicine" (hereinafter referred to as "Guidance Principles")，The development and effectiveness of the clinical trials of the new drugs of traditional Chinese medicine for evidence、Security evaluation provides basic guidance，Prescription sources of new medicines in Chinese medicines in the syndrome、Clinical positioning、Syndrome diagnosis、Basic research ideas of clinical trials、treatment and follow -up、Effective evaluation and safety evaluation、Test quality control and data management、The writing of the manual focuses on the consideration of the consideration of traditional Chinese medicine。
Other general system requirements for clinical trials，There are clear expressions in the relevant technical guidance principles such as "General Principles of Chinese Medicine New Medicine Research"，No stake sports betting appmore details in the "Guidance Principles"。
Basic requirements before clinical trials of new drugs in Chinese medicine category
"Guidance Principles" emphasizes the prerequisites necessary for new Chinese medicines to enter the clinical research stage，For example, the prescription should have sufficient people with the foundation，and in the preliminary clinical practice, the preliminary efficacy and safety of the new Chinese medicine drugs are prompted by a more standardized clinical observation。In view of the current development and research on the development and efficacy of Chinese medicine syndrome models, there are still certain limitations，Therefore, the preliminary data of the new Chinese medicine new medicine for the evidence must be preferred in the level of evidence in the level of evidence。
Basic research ideas for clinical trial design of Chinese medicine new medicines in the category
"Guidance Principles" Suggestions of the new Chinese medicine new drug clinical trial design can adopt a simple Chinese medicine syndrome research mode、The combination of traditional Chinese medicine disease syndrome and research mode to prove the traditional disease，Encouraged developers can choose the appropriate clinical research path according to the characteristics of the variety。but，No matter what research mode，Suggestions from the perspective of evaluation should be preferred by the controller，And advise
