News Archive

Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak

10th April 2020

Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home

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CVMP Draft Reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU

10th April 2020

Deadline for comments 30th April 2020

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Pharmaceutical and diagnostics industries are already responding to Governments call to arms

9th April 2020

We can first ensure that testing is available for patients who need it, then expand testing of critical NHS staff and their families, followed by testing critical key workers, and then the community as a whole. The plan includes a national effort for diagnostics, to build mass testing capacity at a totally new scale. We did not start this crisis with a large diagnostics industry, so instead we are going to have to build one.

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Conduct of remote Investigator Site Audits (ISAs) - Guidance

8th April 2020

TMQA have produced this document on the conduct of remote ISAs.

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MHRA - Flexibility in GxP Labs

8th April 2020

Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak

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Process Licensing Update

3rd April 2020

A blog post by Asif Janjua, Posted on:3 April 2020, to give an update on a change to how the MHRA are issuing their licences and certificates due to the coronavirus pandemic; and a reminder to keep your contact details up to date.

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EMA Regulatory Science to 2025

1st April 2020

EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated so that we can adapt our process in real-time, where needed. The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary. The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.

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Advice for Good Laboratory Practice facilities in relation to coronavirus (COVID-19)

31st March 2020

MHRA Blog Entry: It is recognised that there are potential challenges specific to GLP facilities and studies at this time. The aim of this post is to provide you with information that will enable a flexible but compliant approach during this period.

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