The UK Clinical Trial sector is due to benefit from a recently launched MHRA notification scheme for certain types of initial Clinical Trial Applications (CTAs). This marks the start of an MHRA overhaul of UK clinical trial regulations. The scheme will see the lowest-risk clinical trials processed in less than 14 days (reduced from 30 days).
The scheme will significantly reduce the assessment time for certain Phase 3 and Phase 4 initial CTAs. The scheme does not include CTAs for first in human (FIH), Phase 1 or Phase 2, or amendments at this time.
Eligible Phase 4 CTAs must involve an authorised Investigational Medicinal Product (IMP) used in accordance with the relevant authorisation and with no ongoing safety concerns. Phase 3 CTAs are eligible where the study is already approved in the US or EU, or the IMP has received approval in another Phase 3 study in the UK, or the IMP is already licensed and used in accordance with the relevant authorisation in the UK, US or EU.
Full details of the eligibility criteria are available on the GOV.UK website.
It is important to note that ethics approval will still be required and while the Health Research Authority is also exploring opportunities to complement the new scheme, existing timelines apply for this component of the approval process.
All applicants whose trials meet these criteria should participate in the scheme by registering their interest by completing the online form.
