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艾迪藥業(688488.SH):順利完成ACC007片註冊現場核查
格隆匯 11-12 17:10

格隆匯 11 月 12日丨艾迪藥業(688488.SH)公佈,公司抗艾滋病領域在研1類新藥ACC007片(“ACC007”)繼2020年7月23日境內生產藥品註冊申請獲得受理、8月6日被納入擬優先審評品種公示名單後,公司於9月2日接到國家藥品監督管理局藥品審評中心啟動ACC007藥學、臨牀的註冊現場核查通知,近期完成了國家藥品監督管理局食品藥品審核查驗中心的藥品註冊現場核查。

產品名稱:ACC007片;劑型:片劑;規格:75mg/片;申請事項:境內生產藥品註冊;申報階段:申報生產;申請人:江蘇艾迪藥業股份有限公司;受理號:CXHS2000022。

核查中心專家組於2020年9月至11月期間,先後對ACC007實施了臨牀研究和藥學研究兩方面的藥品註冊現場核查。9月23日-26日,在重慶市公共衞生醫療救治中心、首都醫科大學附屬北京地壇醫院完成了藥品註冊臨牀試驗現場核查;11月4日-8日,在公司原料藥委託生產廠家——海門慧聚藥業有限公司完成了為期5天的藥品研製現場核查及生產現場核查,期間同步實施了上市前藥品GMP符合性檢查;11月9日-12日,在公司完成了製劑的藥品研製現場核查及生產現場核查。

經核查中心專家組嚴格按照現行法規實施核查後,認為ACC007的藥品註冊現場核查(臨牀)沒有真實性問題及重點關注問題,藥品註冊現場核查(藥學)的研製現場及生產現場動態核查無嚴重和主要缺陷,不存在真實性、一致性問題。

公司作為2020年7月1日起實施新政下獲得受理的首批第一家藥品註冊現場核查企業,此次順利完成了ACC007臨牀研究和藥學研究的藥品註冊現場核查,為ACC007獲批上市奠定了良好的基礎。

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