Original title: Five antigen detection kits in Jiangsu have been approved for listing
The reporter learned that the new coronavirus antigen detection kit developed by Jiangsu Meike Medicine and Jidan Biotech was approved by the State Food and Drug Administration for listing. Up to now, 5 companies in our province, including Nanjing Novozyme, Shenji Pharmaceuticals, Wuxi Kezhida, Jiangsu Meike, and Jidan Biology, have approved the marketing of new coronavirus (2019-nCoV) antigen detection kits. It ranks second in the country; among the 5 approved enterprises, 4 are located in Nanjing.
In order to help the province’s antigen detection reagents to go on the market as soon as possible, the Provincial Food and Drug Administration specially organized the establishment of a special work class to implement “one enterprise, one special class” to provide 24-hour registration and declaration services for enterprises, and to guide enterprises to master the declaration requirements. The declaration provides full guidance services. It also actively communicated with the Provincial Health and Health Commission, sorted out 16 clinical problems, coordinated the clinical resources in the province to concentrate on tackling key problems, and effectively accelerated the process of enterprise clinical trials. At the same time, speed up the approval of production licenses, guide enterprises to apply for production licenses as soon as relevant products are approved, and complete the approval of production licenses on the same day. (Reporter Zhong Chongshan)
(Editors in charge: Zhang Xin, Tang Lulu)
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