GXP检查新安排 20200320

New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19)

MHRA因COVID-19重新安排GXP检查

We will only be conducting essential inspections. We are expecting organisations to maintain GxP compliance.

我们将仅执行必要的现场检查。我们期望各组织保持GXP合规性。

Published 20 March 2020

From:

Medicines and Healthcare products Regulatory Agency

 

As part of our response to the coronavirus outbreak, we have decided to conduct only essential Good Practice (GxP) inspections of Laboratories, Clinical Trials, Manufacturing, Distribution and Pharmacovigilance until further notice.

作为新冠肺炎爆发响应工作的一部分，我们已决定仅对实验室、临床试验、生产、销售和药物警戒执行必要的GXP检查，直到有进一步通知。

Other MHRA inspections will be deferred to a later date.

其它MHRA检查将推迟。

Our Good Practice inspections monitor compliance with the MHRA’s UK standards in sites engaged in laboratory studies, clinical trials, manufacturing, distribution, and pharmacovigilance (safety monitoring of medicines). They are conducted both in the UK and overseas.

我们的GXP检查监管的是从事实验室研究、临床试验、生产、销售和药物警戒（药物安全性监管）工作的现场符合MHRA英国标准的情况。这些检查有些在英国，有些在海外。

We are expecting organisations to maintain GxP compliance, and will support the industry and NHS to focus on service continuity by using alternative approaches for routine regulatory oversight, such as office-based assessment and the sharing of information within the international regulatory network.

我们目前期望各组织保持其GXP合规性。我们会通过使用替代方法取代常规的法规监管措施，例如，远程审评和与国际药监机构网络共享信息，以支持企业和NHS集中精力于其服务持续性。

We will prioritise essential on-site inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk, where these sites cannot be assessed remotely. Essential clinical trial authorisation applications will not be affected by this changeand will remain prioritised.

我们会在无法进行远程审评时，优先执行与英国政府的COVID-19响应或任何有其它潜在严重公众卫生风险有关的现场检查。该变化对重要的临床试验许可申报不会产生影响，并保持其优先级别。

We understand current challenges, and are acting inline with UK Government recommendations to minimise the impact of any such inspections on industry and agency personnel wherever possible.

我们了解当前面临的挑战，并且根据英国政府的建议积极采取措施，尽可能降低任何此类现场检查对企业和MHRA人员的影响。

This situation remains under review and we will provide further information as it becomes available.

目前我们对此情况仍在审核中，我们会在有新消息时向大家发布。

If you have any questions on GxP-related issues,please email:

如有GXP相关问题，请发邮件至：

• Good Laboratory Practice: gxplabs@mhra.gov.uk

• Good Clinical Practice: ctdhelpline@mhra.gov.uk

• Good Manufacturing Practice: gmpinspectorate@mhra.gov.uk    

• Good Distribution Practice: GDP.Inspectorate@mhra.gov.uk    

• Good Pharmacovigilance     Practice: gpvpinspectors@mhra.gov.uk

       文章来源：蒲公英制药论坛

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