Regulatory perspectives of combination products

Abstract

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.

Biological Evaluation of Medical Devices in the Form of Suppositories for Rectal and Vaginal Use

“…In the terms of access of the developed medical products, in particularmedical devices to various segments of global pharmaceutical market the problem of unification of regulatory requirements in various states and supranational structures is very important (for example, EU) for managing quality, safety, and efficiency of such products [18,19]. Manufacturers of medical devices and other medical products constantly discuss the issues of interconnection between scientific-technical issues in this sphere in terms of regulatory requirements [20][21][22][23]. Guinea pig with the skin zone, on which "Prodexyn" was applied Guinea pig skin after "Pravenor" testing Guinea pig skin after "Prodexyn" testing There are many products for vaginal and rectal use, which are sold on the developed countries markets, and which are classified as medical devices.…”

New use for old drug: Local delivery of puerarin facilitates critical-size defect repair in rats by promoting angiogenesis and osteogenesis

“…Our previous work has established an excellent porous poly (lactic-co-glycolic acid) (PLGA)/beta-tricalcium phosphate (β-TCP) (PLGA/TCP, PT) scaffold by low-temperature rapid prototyping (LT-RP) technology to deliver bioactive substances, such as icariin, icaritin, salvianolic acid, and magnesium particles, to promote new bone formation in challenging healing bone defects [ [12] , [13] , [14] , [15] , [16] ]. However, the addition of bioactive substances may result in new intended uses with unfavorable factors during bench-to-bedside translation, causing safety and efficacy issues [ 17 ]. In China, drug/device combination products with main effects as medical devices shall be regulated as Class III medical devices, and drugs in combination products should have a drug registration certificate issued by National Medical Products Administration (NMPA) [ 17 ].…”

“…However, the addition of bioactive substances may result in new intended uses with unfavorable factors during bench-to-bedside translation, causing safety and efficacy issues [ 17 ]. In China, drug/device combination products with main effects as medical devices shall be regulated as Class III medical devices, and drugs in combination products should have a drug registration certificate issued by National Medical Products Administration (NMPA) [ 17 ].…”

Translation of biomaterials from bench to clinic

“…A total of 24 articles [ [4] , [5] , [6] , [7] , [8] , [9] , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] ] are included in this special issue. These articles can be categorized in terms of authors, biomaterials and targeted clinical areas, and article types.…”

“…As an emerging field, regulatory science has been gradually developed to play an important role during the translation of innovative biomaterial-based medical products. Several articles in this special issue are on regulatory science and discuss the new standards, tools, and approaches to evaluate the safety, efficacy, quality, and performance of medical products [ 10 , 13 , 17 , 19 ]. This special issue also covers a wide range of article types including research article [ [1] , [2] , [3] , [4] , [5] , [6] , [7] , [8] , [9] , 11 , 12 , 15 , 16 , [18] , [19] , [20] , [23] , [24] , [25] , [26] ], reviews [ 14 , 17 , 21 , 22 , 27 ], perspectives [ 10 , 13 ] and opinion paper [ 18 ].…”