The approvals process for clinical trials

These changes will come into force on 28 April 2026 and apply to all CTIMP applications and modifications (currently known as amendments) submitted from this date.

Applications and amendments submitted before this date follow the current process and legislation.

The following pages give you guidance on how the new regulations will change how applications and modifications are processed and approved:

• the approvals process for applications
• the approvals process for modifications (amendments)
• MHRA and REC requesting modifications post-approval
• approvals lapsing for trials with no recruitment
• the approvals process for Phase 1 healthy volunteer trials