Regulation challenge of tissue engineering and regenerative medicine in China

作     者：Liang Chen Chunren Wang Tingfei Xi 

作者机构：Center for Biomaterials and Tissue EngineeringNational Institutes for Food and Drug ControlPeking University Beijing China Center for Biomedical Materials and Tissue EngineeringPeking University Beijing China 

出 版 物：《Burns & Trauma》 (烧伤与创伤（英文）)

年 卷 期：2013年第1卷第2期

页      面：56-62页

学科分类：0202[经济学-应用经济学] 02[经济学] 020205[经济学-产业经济学] 

基　　金：The present study is supported by National Hightech R&D Program of China (2011AA020104) 

主　　题：Regenerative medicine tissue engineering medical product regulation technique 

摘      要：The current regulatory status in the USA, European Union (EU), Japan, and China, associated with the clinical application of tissue engineering and regenerative medicine is presented. It is found that similar regulatory framework has been constructed in the USA and EU, in which risk-based regulatory strategy is used to determine which regulatory mode is more desirable between medical technique and medical product. Also, it is suggested that two-tier regulatory framework of medical products be constructed, with the first level built on existing and newly introduced regulatory provisions and the second technical level encompassing all the technical requirements. In China, the demarcation line between medical technique mode and medical product mode is not made clear and coherent and flexible regulatory framework has not been intentionally designed. If the recommendations concerning the desirability of regulatory framework will be adopted in China, it means the present application of medical technique mode should be reconsidered and adjusted based on the risk analysis. Furthermore, the construction of two-tier regulatory framework which is tailored to meet the demands of development of medical products of tissue engineering and regenerative medicine still remains a challenge.