New regulations for clinical trials – Join our Route B substantial modifications pilot

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September 2025: This blog provides information about the Route B substantial modifications and why you should sign up to take part in the pilot if you are eligible. We developed new clinical trial legislation in collaboration with the Health Research …

Decentralised Manufacturing: emerging considerations

Decentralised Manufacturing (DM) is the overarching term used in the UK to cover the two elements of the new manufacturing and supply framework: point of care (POC) and modular manufacturing (MM). A cross-agency team of Quality and Clinical Trial assessors, …

A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors

Posted by: , Posted on: - Categories: GDP, Good distribution practice, Wholesale Dealer’s Licence

The aviation and marine sectors are a journey away from the traditional scope of a Wholesale Dealer’s Licence (WDA(H)), and one of unique and specific challenges. The lorries and trucks that supply medicines to hospitals and pharmacies also head to …

MHRA Good Clinical and Laboratory Practice Symposia (11 and 12 February 2025)

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Come and join the next MHRA Symposia in February 2025 and hear the latest on Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) in the UK from MHRA inspectors and regulators. Registration is available on the dedicated symposia website for in-person …

Public Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2

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As a GCP Inspector at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I thought it would be useful to inform you that Annex 2 of the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline has …

DSUR Submissions and Fees are Changing from 1 June 2024

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February 2025: We have updated some details in this blog post to reflect changes to the payment system and annual progress reports (APRs). The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the …

Pharmacovigilance unravelled: highlights of the 2024 MHRA GPvP Symposium

Posted by: , Posted on: - Categories: Good pharmacovigilance practice, Inside the Inspectorate

The world of GPvP is highly regulated, but the 2024 GPvP symposium showcased how regulation, collaboration and innovation can work together to enhance compliance, provide opportunities for better ways of working, and improve patient lives. The Symposium welcomed over five …