The most significant overhaul of UK clinical trial regulation in more than two decades

From 28 April 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) introduce the most substantial change to records retention requirements in over twenty years. Sponsors will be required to retain the Trial Master File (TMF) and other essential clinical trial records for a minimum of 25 years. This represents a fundamental shift away from the historic five year expectation and establishes longterm digital preservation as a regulatory obligation rather than an optional best practice

This reform aligns UK requirements with international expectations under ICH E6(R3) and reflects the reality of modern, data-intensive clinical research, where records must remain complete, secure and readily retrievable across decades.

The new MHRA and HRA update directly affects inspection readiness, technology systems, vendor choices, outsourcing decisions, information governance, and budget planning.

Organisations that rely on short-term storage or archives tied to specific systems risk non-compliance, losing important evidence, and facing disruptions during inspections.

This eBook focuses exclusively on the retention dimension of the 2026 reforms. It explains what the updated regulation requires, what categories of records must be retained for 25 years, the practical and technical challenges of multidecade stewardship, and approaches sponsors can adopt now to build sustainable, inspection ready retention capabilities.