澳大利亚TGA暂停海外GMP检查！

澳大利亚药监局（TGA）发布消息称：将暂停所有国外GMP检查和QMS（质量管理体系）审计，直至另行通知。 已与因暂停GMP检查而直接受影响的申报方联系，并且，在适当时，通知其保持其现有GMP证书的有效性。

到目前为止，已有欧盟、FDA暂停了海外GMP检查，FDA甚至缩减了国内的GMP检查！

以下为官网公告翻译：

Consistent with the Australian Government's latest travel restrictions, the Therapeutic Goods Administration (TGA) has suspended all overseas GMP (Good Manufacturing Practice) inspections and QMS (Quality Management System) audits until further notice .

根据澳大利亚政府最新的出行限制，治疗用品管理局 （ TGA ） 已暂停所有海外 GMP （良好生产规范）检查和 QMS （质量管理体系）审计，直至另行通知。

In addition to our commitment to ensuring that overseas manufacturers meet GMP and QMS requirements, we are also mindful of the need to provide transparent information to sponsors affected by these delays. Sponsors immediately affected by the suspension to GMP inspections have been contacted and, where applicable, advised about maintaining the validity of their existing GMP clearances.

除了承诺确保海外制造商满足 GMP 和 QMS 要求外，我们还意识到需要向受这些延迟影响的申报方提供透明信息。已联系立即受暂停 GMP 检查影响的申报方，并在适当时，通知其保持现有 GMP 许可的有效性。

Currently there is no impact on domestic inspections and audits ; however, we are continuing to monitor the situation and will provide timely updates should there be any change to this position.

目前对国内检查和审计没有影响 ; 然而，我们正在继续监测局势，如这一立场有任何变化，我们将及时提供最新情况。