Regulatory perspectives of combination products

Jiaxin Tian; Xu Song; Yongqing Wang; Maobo Cheng; Shuang Lu; Wei Xu; Guobiao Gao; Lei Sun; Zhonglan Tang; Minghui Wang; Xingdong Zhang

Bioactive Materials (Apr 2022)

Regulatory perspectives of combination products

Jiaxin Tian,
Xu Song,
Yongqing Wang,
Maobo Cheng,
Shuang Lu,
Wei Xu,
Guobiao Gao,
Lei Sun,
Zhonglan Tang,
Minghui Wang,
Xingdong Zhang

Affiliations

Jiaxin Tian: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China; Corresponding author. Center for Medical Device Evaluation, National Medical Products Administration, No.50 Qixiang Road, Haidian District, Beijing, China.
Xu Song: 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; National Engineering Research Center for Biomaterials & College of Biomedical Engineering, Sichuan University, Chengdu, 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, No.10 kehua Street, Chengdu, China.
Yongqing Wang: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Maobo Cheng: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Shuang Lu: Center for Drug Evaluation, National Medical Products Administration, Beijing, China
Wei Xu: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Guobiao Gao: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Lei Sun: Center for Medical Device Evaluation, National Medical Products Administration, Beijing, China
Zhonglan Tang: 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; National Engineering Research Center for Biomaterials & College of Biomedical Engineering, Sichuan University, Chengdu, China
Minghui Wang: 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; National Engineering Research Center for Biomaterials & College of Biomedical Engineering, Sichuan University, Chengdu, China
Xingdong Zhang: 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; National Engineering Research Center for Biomaterials & College of Biomedical Engineering, Sichuan University, Chengdu, China

Journal volume & issue: Vol. 10
pp. 492 – 503

Abstract

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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.

Published in Bioactive Materials

ISSN: 2452-199X (Online)
Publisher: KeAi Communications Co., Ltd.
Country of publisher: China
LCC subjects: Technology: Electrical engineering. Electronics. Nuclear engineering: Materials of engineering and construction. Mechanics of materials; Science: Biology (General)
Website: https://www.keaipublishing.com/en/journals/bioactive-materials/

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