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MHRA updates guidance page on GCP inspections for clinical trials of medicines

🇬🇧 MHRA · Fri 06 Nov 2026

The UK regulator's page, last updated 6 November 2026, sets out risk-based and triggered inspections, dossier requests and the inspection process, with ICH E6(R3) as the reference standard.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance page on good clinical practice (GCP) inspections, with the latest revision dated 6 November 2026. The page was first published on 18 December 2014. The extract available does not say which sections were changed, so the specific revisions cannot be identified here.

The page points to ICH E6(R3) as the GCP guideline. It describes the guideline as made up of overarching principles, Annex 1 on interventional trials, Annex 2 on additional considerations for non-traditional interventional trials, a glossary and appendices. It also refers readers to separate MHRA guidance on implementing ICH E6(R3) in the UK and to UK-specific annotations.

Organisations expected to comply include pharmaceutical companies, contract research organisations, providers of trial-specific computerised systems, universities, NHS hospitals, charities, GP practices and laboratories analysing trial samples. The MHRA requires sponsors to notify it of serious breaches. It may carry out triggered inspections where serious breaches are suspected, routine risk-based inspections, and inspections of trials submitted in support of marketing authorisation applications.

Most inspections fall under the risk-based compliance programme and may be systems-based or trial-specific. Systems inspections examine how an organisation runs its trials, with inspectors selecting several trials and sometimes visiting one or two investigator sites. Risk is assessed using internal information such as clinical trial and marketing authorisation applications and inspection history, organisational changes and external intelligence. Phase I units in the accreditation scheme are also inspected regularly.

Organisations considered for inspection are notified and asked for a GCP inspection dossier and a clinical trials spreadsheet within 30 days, unless the inspection is unannounced. Separate templates exist for computerised systems. The dossier informs whether an inspection is needed and its scope. The MHRA says the complete trial master file is the basis for inspection, and all its records must be available to inspectors.

What it means for your team

  • Compare the current page with your inspection-readiness procedures, as the source does not specify what changed on 6 November 2026.
  • Check that dossier and spreadsheet templates, including the computerised systems versions, are current and can be completed within the 30-day window.
  • Make sure the full trial master file, including electronic records, can be made available to inspectors.
  • Review serious-breach notification and triggered-inspection processes, since inspections can follow with little or no notice.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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