On October 29, 2020, hosted by the Zhuhai High-tech Zone Science and Technology Industry Bureau, undertaken by the Zhuhai High-tech Zone Biomedicine and Medical Device Industry Office, and supported by Guangdong Medical Valley, the Biomedical Industry Clinical Trial Seminar and Biomedical and Medical Device Industry Alliance Preparatory Meeting was successfully held in Zhuhai High-tech Zone.
At the beginning of the event, Mr. Zhang Hanming, Director of the Science and Technology Innovation and Industrial Development Bureau of Zhuhai High-tech Zone, made an opening speech, introducing the development of the biomedicine and medical device industries in Zhuhai High-tech Zone. At present, Zhuhai High-tech Zone has 3 provincial-level new research and development institutions such as Zhuhai Advanced Institute of Science and Technology, 13 engineering centers and enterprise technology centers at all levels, 2 academician workstations, 7 post-doctoral innovation practice bases (workstations), and the Fifth Institute of Zhongda University 1 Translational Medicine Collaborative Innovation Center.
Mr. Zhang Hanming, Director of the Science and Technology Innovation and Industrial Development Bureau of Zhuhai High-tech ZoneAfter years of cultivation and development, it has now formed an ecological collection of six characteristic product categories, including blood purification, life monitoring equipment, medical imaging equipment, minimally invasive interventional devices, in vitro diagnostic reagents, and genetic medicine. It has world-class blood purification equipment and genes. Pharmaceuticals, gene chips, digital X-ray systems, CT tubes and other products have emerged from many well-known companies in the industry, such as Jianfan Biological, Essex Biological, Biolight, Utimer, Tongqiao Medical and Pumis. In the past five years, the scale of the biomedicine and medical device industry in Zhuhai High-tech Zone has grown rapidly, with an average annual growth rate of more than 20%. In 2019, the biomedical industry achieved a total output value of 5.5 billion yuan. Up to now, the total number of biomedical companies in the district has exceeded 100, accounting for about one-third of the total number of biomedical companies in the city, including 20 regulated industrial companies, 3 listed companies, and 7 selected municipal unicorn enterprise cultivation banks.Mr. Chen Jiaye, Deputy Director of the Administrative Licensing Division of Guangdong Provincial Drug Administration, focused on the interpretation of the relevant policies of the Guangdong Medical Device Registrant System. The pilot system of medical device registrants in Guangdong Province has been implemented since August 14, 2018. Since the implementation of the pilot work for two years, as of October 23, 2020, a total of 64 pilot varieties have been approved for listing, and nearly 360 varieties have entered the market. The pilot channel for registrants is in the stage of registration inspection or review, and nearly 500 varieties are interested in participating in the pilot. The implementation of the medical device registrant system, that is, the medical device marketing authorization holder system, is one of the important contents of deepening the reform of the medical device review and approval system and encouraging medical device innovation.
Ms. Yang Min, deputy director of the clinical trial organization of Guangdong Provincial People's Hospital, introduced the clinical trial resources and cooperation methods of Guangdong Provincial People's Hospital. Guangdong Provincial People's Hospital leads the province in its clinical trial capabilities. Currently, there are more than 300 clinical trials in research and registration, and the institution has undertaken more than 1,000 clinical trials so far. Institutions’ participation in international multi-center test projects continues to increase. Some departments organize large-scale international and domestic multi-center tests, and their recognition and popularity among domestic and foreign counterparts and sponsors continues to increase. In the future, it will further improve the quality of clinical trials, increase output, maintain the level of domestic first-class clinical trial institutions, and contribute to the development of China's biopharmaceutical industry.
Mr. Huang Xi, Academic Director, Professor, Chief Physician, and PhD Supervisor of the Fifth Hospital of CUHK introduced the clinical experiment resources and cooperation methods of the hospital. The Fifth Affiliated Hospital of Sun Yat-sen University has been recognized as a drug clinical trial institution since 2005, and currently has nearly 300 registered clinical trials. Through continuous improvement of the organization and management structure, strengthening of standardized construction, strengthening GCP-related knowledge training, and multi-dimensional guarantee of clinical trial quality, Continuously explore the management model suitable for this institution. In the future, efforts will be made to build an information platform for clinical trials to make clinical trials more standardized and better managed.
Delegates at the conference agreed that multiple measures are needed to promote cooperation between hospitals and enterprises, and on the basis of the collaborative innovation center of the High-tech Zone and the Fifth Hospital of Zhongda, to promote more clinical trial institutions in tertiary hospitals and corporate clinical trials for joint development.
