The Medicines and Healthcare products Regulatory Agency (MHRA) announced that 100 clinical trial applications have now been authorised via their Combined Ways of Working (CWoW) pilot scheme. In 2019, the scheme was enrolled with an aim of simplifying clinical trial applications by establishing a single application route and a coordinated ethics and regulatory review for clinical trials. The CWoW has now approved 100 clinical trials, ranging through every phase of development, including first-in-human studies.
Under the CWoW, sponsors can expect a single UK decision in an average of 54 days, compared to 91 days outside of CwoW. More rapid decisions are expected for phase I trials. Furthermore, sponsors can efficiently plan their studies with the confidence that the timeframes for approval are more consistent under CWoW.
Recently, efforts are being made to enhance the Integrated Research Application System (IRAS) which will streamline the process even more. The MHRA, and Health Research Authority (HRA) are collaborating to launch a new automated technical solution for applicants to use.
“All this adds up to the most important benefit – helping innovative new medicines reach UK patients faster.”
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