- 2024,11,05
From October 26th to 27th, Chen Kui, Deputy Director of the Provincial Drug Administration, led a team to Wenzhou to carry out research and service activities on the "three for". Chen Yunyuan, Deputy Director of the Municipal Bureau, and others accompanied the investigation.
Chen Kui and his delegation successively held symposium and exchange meetings at Wenzhou Municipal Bureau and Wenzhou Medical University, listening to reports on Wenzhou's drug regulatory work and drug safety special rectification actions, the progress of drug clinical trial collaborative management platform work, and the construction of China Gene Medicine Valley and China Eye Valley; Visit and research Zhejiang Chengyi Pharmaceutical Co., Ltd. and Zhejiang Haikang Biological Products Co., Ltd. to understand the relevant situations and difficulties in the application and construction of the enterprise's "black box". Chen Kui fully affirmed the relevant work of Wenzhou Municipal Bureau, highly praised its role in the evaluation of the national vaccine regulatory system, appreciated the pilot project of ethical mutual recognition of Wenzhou collaborative management platform, gave suggestions and guidance on the next step of Wenzhou Municipal Bureau, and gave on-site guidance to the National Engineering Research Center of China Gene Drug Valley Cell Growth Factor and Protein Drugs, Answer the questions raised by enterprises and institutions one by one.
During the research period, Chen Kui emphasized the need to firmly adhere to the bottom line of drug safety. Regulatory authorities need to increase regulatory efforts, deepen drug safety governance, and build a long-term governance mechanism. Every link and position in enterprise production should maintain a cautious and conscientious attitude, strictly self inspect according to standards, and effectively standardize production. Secondly, we need to improve the level of drug governance. Especially, ethical mutual recognition in drug clinical trials should rise from consensus among institutions to building systems, formulating norms, and then moving towards standardization. Thirdly, we need to accelerate the development of the pharmaceutical industry. We should base ourselves on the actual situation in Zhejiang and Wenzhou, strengthen the deep integration of industry, academia, and research, and continue to promote the high-quality development of health industries such as Eye Valley and Pharmaceutical Valley. We should actively guide the sincere pharmaceutical industry to rely on the advantages of marine biological resources and expand and strengthen the marine biopharmaceutical industry. We need to promote the integration of blood and plasma collection by Haikang Biological, strive for innovation in one place, and promote it throughout the province. Fourth, we need to improve satisfaction with drug safety. Especially, we need to increase the promotion of drug safety and the construction of livelihood services such as pharmaceutical service stations, to enhance the public's sense of safety and gain in medication. (Department of Drug Regulation)