Perspective on Registration of Clinical Trial of New Traditional Chinese Medicines
10.11842/wst.2016.12.007
- VernacularTitle:从注册管理的视角谈中药新药临床试验
- Author:
Hainan WANG
- Keywords:
Registration;
new traditional Chinese medicines;
clinical trial;
data management
- From:
World Science and Technology-Modernization of Traditional Chinese Medicine
2016;18(12):2070-2074
- CountryChina
- Language:Chinese
-
Abstract:
With the reform of drug evaluation and approval in advance,a series of new initiatives have be launched,including improving the drug registration classification,revision of GCP and carrying out clinical trial data verification,strengthening clinical trial data management etc.Clinical trials of traditional Chinese medicines are facing new opportunities and challenges.The development of new traditional Chinese medicines should meet the clinical needs and clearly answer the clinical problems.The effectiveness of traditional Chinese medicines can be measured,and the key is to grasp scientific and reasonable research methods.Clinical trials of traditional Chinese medicines should pay attention to the research logic of clinical trials,and pay more attention to the quality of clinical trial data.The efficacy of traditional Chinese medicines is indeed based on clinical data.Viewed from its tendency,new Traditional Chinese Medicines are based on compound prescription.Therefore,researchers should effectively improve the overall research quality of the clincal trials on the new medicines of traditional Chinese medical compounds.
