Commissioned by the Department of Science and Education of the National Health Commission, the 2023 dated 24 May, the stem cell clinical research verification expert group (hereinafter referred to as“Expert Group”) visited Chengdu World Health Health Biotechnology Co. , Ltd. (hereinafter referred to as“World Health”) to conduct on-site supervision and verification work. The expert group was led by Wu Zhaohui, vice chairman of the China Association of Pharmaceutical Biotechnology, Zhang Wen, director of the Information Services Department and Director of the Association, and Professor Zhang Shuren of the Institute of Oncology, Chinese Academy of Medical Sciences, professor Wang Lisheng, Institute of Stem Cell and translational medicine, Affiliated Hospital of Qingdao University.

The meeting was chaired by Wu Zhaohui, vice chairman of the inspection team, and attended by the founder and Chief Scientist of the World Alliance Health, Professor Tian Weidong, and general manager Tang Yingfeng. Vice-chairman Wu Zhaohui stressed that this supervision and verification work aims to implement the requirements of stem cell clinical research work, strengthen the supervision of stem cell clinical research, and promote the standardized and orderly development of research work, it includes on-site supervision and verification from on-site hardware verification to document implementation effect.

Professor Tian Weidong said that during the development of the company, especially for stem cell clinical research work, the company has always adhered to the“Professional-oriented, standard-first, quality-oriented” overall development ideas and requirements, the aim of the development is to establish a quality management system in accordance with GMP standard, which is based on the clinical research of stem cells and the research and development of cell drugs. As the founder and chief scientist of stem cell clinic, Professor Tian Weidong gave a brief introduction of the company, the progress of stem cell clinic research and GMP construction.

After the report, the group of experts arranged on-site equipment, facilities, signs, etc. , comprehensive verification was carried out on personnel training, personnel qualification requirements, cell quality control standards, warehousing and storage management, release of finished products, and protection of the rights and interests of suppliers, and with the production, quality-related personnel to do a full communication. After understanding the construction of the company's hardware and software, the expert group formed a final consensus on the verification of the situation, that the world union health with drug quality management standards combined with the specificity of cell therapy products, a quality assurance system of whole process and multi-aspect was established to meet the requirements of clinical research and preparation institutions of stem cells. At the same time, the expert group on legal training, study, product release inspection made more reasonable recommendations. Taking the opportunity of this supervision and verification, the world union health organization will form a quality self-audit system. At the same time of external inspection, the combination of external audit and self-audit will further improve quality management standards and promote the strengthening of cell quality and safety requirements, to provide better services for stem cell clinical research institutions, promote the healthy and rapid development of the industry, and help the industrialization of scientific research achievements in the field of cell technology in Sichuan Province, efforts to introduce clinical drugs to fill the domestic gaps in stem cell drug therapy.