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白雲山(600332.SH):廣藥總院通過GLP定期檢查並獲得《藥物GLP認證批件》
格隆匯 07-13 18:55

格隆匯7月13日丨白雲山(600332.SH)公佈,公司獲悉,公司全資子公司廣州醫藥研究總院有限公司(“廣藥總院”)於2021年7月12日收到國家藥品監督管理局藥品註冊管理司《關於廣州醫藥研究總院有限公司(藥物非臨牀評價研究中心)藥物非臨牀研究質量管理規範定期檢查結果的通知》及國家藥品監督管理局頒發的《藥物GLP認證批件》。

經審核:廣藥總院(藥物非臨牀評價研究中心)在藥物安全評價的組織管理和人員、儀器設備和實驗材料、標準操作程序以及試驗運行等方面基本符合GLP要求,申請的單次和多次給藥毒性試驗(齧齒類)、單次和多次給藥毒性試驗(非齧齒類)、生殖毒性試驗(Ⅰ段、Ⅱ段)、遺傳毒性試驗(Ames試驗、微核、染色體畸變)、局部毒性試驗、免疫原性試驗、安全性藥理試驗、毒代動力學試驗項目符合GLP定期檢查要求。

廣藥總院為公司主要研發平台之一。廣藥總院(藥物非臨牀評價研究中心)本次通過GLP定期檢查及認證檢查,具備了9項非臨牀評價項目資質能力,有利於承接自主研發項目和對外承接藥物非臨牀安全性評價業務,有助於公司提升研發創新綜合實力。

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