News Archive

MHRA - 2021-2022 Fees

7th April 2021

Fees payable to the MHRA for 2021 to 2022

MHRA - Innovative Licensing and Access Pathway

7th April 2021

A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.

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MHRA - Responding to a GLP and GCP laboratory inspection report

7th April 2021

Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports.

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MHRA - The Target Development Profile Toolkit

7th April 2021

This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.

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MHRA - updates to GLP for safety tests on chemicals

7th April 2021

30 March 2021 Added new information on the inspector providing a verbal summary of GLP monitoring inspection findings. Added a link to a new page on responding to a GLP and GCP laboratory inspection report.

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MHRA - Stakeholder Engagement Meeting March 2021

26th March 2021

The MHRA GCP Stakeholder Engagement Meeting (StEM) now meets on an annual basis to provide a forum for discussion between the MHRA GCP inspectorate and represented stakeholders on key topics related to the conduct of clinical trials of investigational medicinal products....

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