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Medical bio-collagen empowered by technology for a promising prospect

2023-03-08


Newsletter from China Pharm Website, on September 27-29, "2021 medical collagen regulatory policy and economic technology innovation conference and the eighth national medical collagen industry academic conference" was held in Guangzhou. The meeting was sponsored by Pharmaceutical Economic News, Guangdong Medical Device Management Society and Guangdong Medical Collagen Engineering Technology R&D Center. It is the eighth time that Guangzhou Trauer Biotechnology Co., Ltd. organizes the forum. A group of industry experts including Wang Yingjun, the academician of Chinese Academy of Engineering and academician of Asia Pacific Academy of Materials, attended the conference. Chen Xiaofeng, the vice president of Chinese Biomaterials Society and professor of Materials collage of South China University of Technology, presided over the conference.

The national academic conference of medical collagen has been successfully held for seven times since 2013. The theme of this conference is " develop with accumulation, lead with innovation, regulate with science, and create the future with technology”. The conference revolved around the trends of scientific regulatory policy for innovative collagen-based medical devices, looked back and forward the development of medical collagen and discuss about the technology innovation and application of medical collagen as well as the economic frontier and drive of collagen material industry.


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Give impetus to the innovation and development of medical collagen with joint efforts

Wang Yingjun pointed out, "In recent years, the whole medical collagen industry has undergone enormous changes with more automated and intelligent equipment being introduced. 3D printing technology, innovative research and application of stem cells, and the compound of collagen with other materials in the field of tissue engineering have also been extensively used. Medical collagen-based tissue engineering  products are developing towards refinement, biomimetic, functionalization and diversification."

In the industry of medical collagen, the Medical Devices Standards Management Center of national medical products administration has been working on the naming, classification guidelines, revision work of  criterion, as well as organizing a number of regulatory, standards, academic and industry representative online communication conference, to discuss and negotiate the policy aiming to promote the development of  China's medical collagen materials and medical industry in a scientific and standardized manner, thereby leading to a sound development in the industry.

Zhong Yongqiang, honorary president of Guangdong Medical Device Management Association, pointed out that collagen is extensively found in human tissues and plays an important role in physiological activities. The collagen industry is an industry with decades of accumulation and experience, dynamic, innovative and creative. These years have seen increasing influence and popularity of the National Medical Collagen Industry Academic Conference, and now it has become an pivotal platform for innovation and communication in the collagen industry.

Tong Gang, chairman of Guangzhou Trauer Biotechnology Co., Ltd. said: "After 19 years of practice and refinement, Trauer Biotechnology has continued to increase its investment in research and development for medical collagen and enhance its core technology capability. In order to further drive the sound development of medical collagen materials and industry, the medical collagen engineering technology research and development center of Guangdong Province which based on the construction of Trauer, decided to set up biocollagen raw material R&D innovation award entitled by academician Wang Yingjun' in this conference. The establishment of the Academician Innovation Award is expected to further support the innovative research and development of collagen-based biomaterials across nation and globe, the transformation results from industry, academia and research as well as application innovation, which promote the high-quality development of the active collagen in China."

 

A promising future for the development of medical collagen

In the report session, the relevant personnel, from the National Medical Administration department, Guangdong Medical Administration department and Medical Device Technical Review and Inspection  Center of Great Bay Area, delivered impressive speeches on the topics including scientific regulation of collagen industry, classification principles and standardization research.

Zhao Peng, Deputy Director of Review Department III of Medical Device Technical Review Center in National Medical Administration, introduced the key points for the safe and effective evaluation of collagen-based medical devices, such as mechanical strength, sterilization, material characterization, stability, impurity control, and biosafety. In addition, Zhao Peng suggested that the transformation of innovative medical devices should weigh up the relationship between the innovation point and the overall risk benefit, improve the activeness and effectiveness of communication, pay attention to the comprehensive and objective output of information, actively participate in regulatory scientific research, and respond to the whole industry chain linkage.

Zhang Feng, Director of Medical Device Supervision and Administration Division in Guangdong Medical Administration,  stated that Guangdong Medical Administration continue to promote the rapid and high-quality development of medical device industry in Guangdong Province in 2021 by following 5 aspects. First, strengthen the whole life cycle management of medical devices, risk management, and promote the development of regulatory science; second, continue to engage in-depth reform of review and approval system for drug medical device and innovative medical device; third, work on enhancing the modernization and clustering of high-end medical device industry chain; fourth, fully support enterprises to become better and stronger; fifth, accelerate the cultivation and introduction of talents in medical device.

 

The nation set a high value on the establishment standard system and quality evaluation system

Liu Bin, director of the Medical Device Technical Review and Inspection Center in Great Bay Area of National Medical Administration, stressed that collagen-based materials have great application prospects and market potential in the field of medical devices. Since the first regulatory science conducted research on key projects, great breakthroughs have been made in new standards, new tools and new methods for recombinant collagen. The regulation of both drugs and medical devices under the new situation must keep pace with the times. It extends to the R&D stage to the whole life cycle of products, so as to strengthen the foundation, complement the shortcomings, overcome the bottlenecks and boost improvement; additionally, it facilitates the innovation context by integrating top social resources at home and strengthening communication and cooperation with international regulatory agencies abroad, so as to achieve a win-win cooperation for mutual benefit.

In the video report, Xu Liming, Director of the Quality Evaluation Office of Medical Device Testing and control Institute in the National Institutes for Food and Drug Control, pointed out that the collagen is mainly manufactured and prepared by emerging SEMs, which feature by insufficient investment in process research and development, uneven product quality, and lack of comprehensive characterization methods and identification means. It is great concern to control the quality of the raw materials used in the medical field, and there is a lack of scientific evaluation system whether the expected advantages of collagen can be realized and the tissue regeneration, repair and reconstruction can be achieved. Meanwhile innovative medical products related to collagen are constantly emerging. There is no systematic characterization and quality evaluation system for collagen-based products, which lags behind the  industrial development. Therefore, a standard system and quality evaluation system need to be established.

Yu Xinhua, director of the Medical Device Standards Management Center of the National Medical Administration, attended the meeting via video online. From his perspective, in recent years, China takes the leading position in the field of recombinant collagen in the globe-wide, and the initial scale production has been achieved and applied to a variety of industry including medical devices, cosmetics, among others. According to incomplete statistics, 43 recombinant collagen medical device products have been completed or are in the course of registration or archive filing. They are mainly applied as human tissue repair materials, medical wound dressing, etc. However, it is a concern that the name of some listed products is not uniform and not standardized, which cause trouble in the identification of products, thereby adversely affecting  high-quality development of the industry and bringing about difficulties for supervision.

In the afternoon of September 28, speeches are delivered revolving around collagen research progress and application by Zhang Guifeng, researcher of Institute of Process Engineering, Chinese Academy of Sciences; Ye Chunting, chief scientist of Guangdong Medical Collagen Engineering Technology R&D Center; Zhang Yuan, deputy director of Special Committee on Regenerative Medicine and Biomaterials, National Association of Health Industry and Enterprise Management; Fan Yujiang, professor of National Biomedical Materials Engineering Technology Research Center; Chen Yunhua, professor of collage of Material Science and Engineering, South China University of Technology; and Xu Xinrong, executive deputy director of Medical Device Research and Inspection Center, South China University of Technology. On September 29, experts and the responsible personnel in enterprises engaged in discussion about trending topics of collagen industry. (Chen Hairong)



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