Interpretation and Drafting Instructions of General Guidelines of Clinical Trials on New Drugs of Traditional Chinese Medicine (TCM)
10.11842/wst.2016.12.008
- VernacularTitle:中药新药临床研究一般原则解读和起草情况说明
- Author:
Binglin LIU
- Keywords:
New drugs;
traditional Chinese medicine;
clinical trials;
the general guideline of clinical trials;
effective evaluation;
safety evaluation
- From:
World Science and Technology-Modernization of Traditional Chinese Medicine
2016;18(12):2075-2081
- CountryChina
- Language:Chinese
-
Abstract:
This paper described the drafting background,including the process and division of labour,of the general guidelines of clinical trials on new drugs of TCM (hereinafter called the guideline) published by China Food and Drug Administration (CDFA) in 2015.The paper mainly introduced the key content and outstanding characteristics of the guideline.The guideline indicated that purpose and target of the clinical trials on the new drugs of TCM should be in accordance with clinical practice and bring clinical benefits to the patients.Besides,the guideline stipulated that the risk/benefit assessment was requisite before marketing a new drug,emphasizing the importance of adequate exploratory clinical trials,scientificalness of the disignation of the endpoints of clinical efficacy,and the significance of the quality control of clinical trials.The specific requirements for the safety evaluation of the heart,liver and kidney was raised and a request for the preparation of the placebo formulated in the guideline.At the same time,the existing problems and the future development of the guideline are discussed in this paper.
