MHRA Updates Guidance on Archiving and Retention of Clinical Trial Records
On 14 April 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published updated guidance on the archiving and retention of clinical trial records, aligned with the amended Medicines for Human Use (Clinical Trials) Regulations, which come into force on 28 April 2026.
Key regulatory alignment
The guidance clarifies that investigators and sponsors must follow this guidance to ensure compliance with the amended regulations. It also aligns with ICH GCP E6(R3), particularly regarding the definition and management of essential documents.
“Essential documents” are defined as those that:
Enable evaluation of trial conduct and data quality, and
Demonstrate compliance with regulatory requirements and Good Clinical Practice (GCP).
Extended retention requirements
A major update concerns retention timelines:
At least 25 years for:
Trial Master File (TMF) documents
Investigator Site Files
Participant medical records
Additional retention:
If data supports a UK marketing authorisation, documents must be retained for at least 2 years after approval
For authorised products:
Documentation must be kept for the duration of the product authorisation, with the final clinical study report retained 5 years after withdrawal
Specific cases:
Advanced therapy products: traceability records must be retained for 30 years after expiry
Medical records may require longer retention depending on other legislation or institutional policies
Transitional provisions clarified
The guidance distinguishes between trials submitted:
Before 28 April 2026:
TMF retention remains 5 years (legacy requirement)
Patient records: 25 years
On or after 28 April 2026:
TMF retention increases to 25 years
All trials must comply with most aspects of the new Regulation 31A, with specific exceptions for legacy provisions.
Stronger expectations for data integrity and archiving systems
The MHRA reinforces expectations from its GxP Data Integrity Guidance, including:
Restricted access to archived records
Retention of originals or certified copies
Validation of digitisation processes
Maintenance of audit trails and metadata for electronic systems
Protection against environmental risks and unauthorised access
Governance and accountability
Sponsors must:
Appoint a named individual responsible for archiving
Ensure oversight of both paper and electronic records
Maintain continuous accessibility and inspection readiness
The guidance also clarifies responsibilities in case of:
Transfer of ownership → new owner assumes archiving obligations
Sponsor closure → responsibility shifts to the Chief Investigator
Implications for manufacturers
For manufacturers involved in clinical investigations (including those supporting UKCA marking or post-market clinical follow-up), this update reinforces several practical considerations:
Long-term data strategy: systems must support retention up to 25+ years
Digital archiving validation becomes critical for compliance
Alignment with ICH GCP E6(R3) may require updates to existing procedures
Legacy trials vs new trials must be clearly distinguished in documentation practices
Inspection readiness must be maintained over significantly longer periods
Conclusion
The updated MHRA guidance formalises a significant shift toward longer retention periods and stricter data governance, bringing UK requirements closer to international expectations under ICH GCP E6(R3).
Manufacturers and sponsors should review their archiving systems, TMF structures, and data integrity controls to ensure alignment before the 28 April 2026 implementation date.
Read the full document below.
