News Archive

Pharmacovigilance Inspection Metrics April 2018 to March 2019

20th April 2020

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019. The full metrics report is available on GOV.UK.

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MedDRA Version 23.0 Update to be Produced

15th April 2020

The ICH MedDRA Management Committee has decided to provide the new COVID-19 terms within the MedDRA dictionary in a very expedited fashion, given the current very exceptional time with the COVID-19 pandemic demanding flexible approaches to ensure that any scientific and medical information from the COVID-19 outbreak can be captured, shared and analysed appropriately.

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Guidance on regulatory requirements in the context of the COVID-19 pandemic

14th April 2020

The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.

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MHRA New opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.

14th April 2020

Guidance on coronavirus (COVID-19) tests and testing kits - updated with new opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.

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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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