The Medicines and Healthcare products Regulatory Agency (MHRA) is ensuring that the UK remains one of the best places in the world to deliver safe, cutting-edge research. As a part of this work is the combined review, which will provide a more streamlined and efficient service for research applicants.
From January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK will be subject to a combined review from the MHRA and the UK Research Ethics Services, in collaboration with the Health Research Authority (HRA), facilitating rapid start-up and benefitting patients sooner.
Applicants need only make a single application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion and approval is delivered together.
A number of sponsors have already used this new process with some reporting a 30 percent improvement in overall trial setup times.
The recently launched implementation plan for the government’s Recovery, Resilience, and Growth (RRG) program for UK clinical research, begins to turn the UK vision for clinical research delivery into a reality.
Комментарии