Pilot to test a combined MHRA-REC approval process

The HRA and MHRA are exploring ways to streamline approval and ongoing management of CTIMPs through a combined ways of working pilot. The pilot  brings together the two organisations’ regulatory approvals, streamlining the process in a way that would fit with the EU’s new Clinical Trial Regulation.

The pilot process requires a single CTIMP application to be submitted for both the CTA and the REC opinion. Applicants then receive a combined communication to request any further information required and a single communication to confirm the final decision.