中药新药临床研究一般原则解读和起草情况说明

Interpretation and Drafting Instructions of General Guidelines of Clinical Trials on New Drugs of Traditional Chinese Medicine (TCM)

本文就2015年国家食品药品监督管理总局新颁布的中药新药临床研究一般原则(简称"指导原则")的起草过程和起草工作分工情况进行了说明,并介绍了本指导原则的重点内容和突出特点。指导原则提出中药新药临床研究目的和定位应该符合临床实际,并能够给患者带来临床受益。而且,指导原则规定中药新药上市需要进行风险/受益评估,强调了充分的探索性临床试验的重要性、临床疗效终点指标设计的科学性、临床试验质量控制的重要性。另外,该指导原则明确提高了心、肝、肾脏安全性研究与评价的具体要求,制定了安慰剂制备的原则要求。最后,本文对指导原则制定中尚存的不足之处和未来发展进行了探讨和展望。

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.