HRA updates Good Clinical Practice inspection guidance

22nd September 2026

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has revised its Good Clinical Practice (GCP) inspection guidance to clarify requirements for inspection dossiers and introduce a specific dossier for organisations providing computerised systems in support of clinical trials. The guidance was also updated on 16th September to include MHRA position statements and guidance on electronic health records. These changes are particularly relevant to sponsors, contract research organisations and technology providers preparing for regulatory inspections, reinforcing the importance of appropriate documentation and oversight of clinical trial systems.

Link: https://www.gov.uk/guidance/clinical-trials-for-medicines-good-clinical-practice-inspections

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