The field inspection of recombinant human follicle stimulating hormone for injection has been completed

CFDA website January 6 The information shows that the application status of recombinant human follicle stimulating hormone for injection of heavy biological products of Jinsai Pharmaceutical Co., Ltd., a subsidiary of Changchun hi tech, has been changed to "report has been transferred to the drug Audit Center", which means that the drug has completed the on-site inspection of production registration and will enter the three in one comprehensive review If the follow-up progress is smooth, it is expected to obtain the production approval document within half a year Recombinant human follicle hormone for injection was used to treat infertility Guotai Junan research report pointed out that at present, the recombinant follicle stimulating hormone in the domestic market is only an imported product, which is expensive FSH of Jinsai pharmaceutical is the first domestic recombinant product, which is expected to be priced at half of the price of imported products, with good safety and efficacy It is expected to be replaced by imported products quickly after listing It is a new drug for Changchun hi tech According to the public information, Kinsey pharmaceutical applied for the clinical approval document of the drug in October 2006 and was approved for clinical application in 2008 In July 2010, the company applied for production approval documents, and was twice notified to issue supplements, so the approval process was rather rough In August last year, the product entered the drug registration on-site inspection and the new GMP certification of the production workshop At present, the GMP certification of the production workshop of the product is still in the stage of "comprehensive assessment of on-site inspection" (class C)