The West London and GTAC is the committee nominated by the HRA to carry out the functions of the GTAC. There are three other committees that can review gene therapy application which are York, Oxford A and Scotland A.
GTAC processes are now consistent with those of other RECs. The time taken for approvals made has reduced by more than half. The last approvals before the HRA took responsibility took 93.5 days; the most recent approval since the transfer took 39 days. The graph below demonstrates the reduction in time taken for approvals since GTAC’s move to the HRA.
During GTAC’s transition to HRA, we clarified the respective roles of MHRA and GTAC, particularly around review of science and timelines.
What needs to be submitted to GTAC?
Legally only gene therapy clinical trials need to be submitted to GTAC, but some stem cell studies like those submitted to the MHRA’s Expert Advisory Group (EAG) are also submitted. GTAC and MHRA are working together to draw up further guidance.
Support for new GTAC arrangements
Keith Thompson, Cell Therapy Catapult said: “The improving regulatory environment in the UK is a positive factor in discussions with potential inward investors and firms operating in the UK who are wanting to set up clinical trials in cell and gene therapy.”
Paul Whiting, Pfizer Neusantis, said: “We welcome the recent changes to GTAC, particularly the improved response times and the clearer focus of responsibility. This is a step in the right direction to enable regenerative medicine clinical research to prosper in the UK.”