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白雲山(00874.HK):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 19:18

格隆匯7月13日丨白雲山(00874.HK)公吿,廣州白雲山醫藥集團股份有限公司(“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》。現將相關情況公吿如下:

本次通過GLP定期檢查及獲得《藥物GLP認證批件》的有關情況:根據《中華人民共和國藥品管理法》和《藥物非臨牀研究質量管理規範認證管理辦法》的規定,國家藥品監督管理局對廣藥總院(藥物非臨牀評價研究中心)執行《藥物非臨牀研究質量管理規範》(“GLP”)的情況進行了定期檢查及認證檢查。廣藥總院順利通過本次GLP定期檢查,並獲得了《藥物GLP認證批件》,新增2項認證資質。

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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