Regulatory perspectives of combination products

Bioactive Materials

Guobiao Gao¹  Xu Song²  Lei Sun³  Zhonglan Tang⁴  Maobo Cheng⁴  Shuang Lu⁵  Minghui Wang⁶  Wei Xu⁷  Jiaxin Tian⁸  Xingdong Zhang⁸  Yongqing Wang⁹ 

[1] College of Biomedical Engineering, Sichuan University, Chengdu, China;Corresponding author. Center for Medical Device Evaluation, National Medical Products Administration, No.50 Qixiang Road, Haidian District, Beijing, China.;;Corresponding author. NMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial &;Institute of Regulatory Science for Medical Devices &NMPA Research Base of Regulatory Science for Medical Devices, Sichuan University, Chengdu, China;NMPA Research Base of Regulatory Science for Medical Devices, Sichuan University, No.10 kehua Street, Chengdu, China.;;National Engineering Research Center for Biomaterials &Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China;;NMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial &

关键词: Combination products;    Definition;    Designation;    Safety and efficacy;    Regulatory science;   

DOI  :  

来源: DOAJ

【 摘 要 】

Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination products are complex and challenging. This review firstly introduced the origin, definition and designation of combination products. Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented. Preclinical and clinical evaluation of combination products was discussed. Lastly, the research prospect of regulatory science for combination products was described. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality and performance of combination products. Taken together, the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

【 授权许可】

Unknown