The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the MHRA is changing. From 01 June 2024, ASRs such as the Development Safety Update Report (DSUR) will not be considered valid unless …
As the regulator, the safety of those volunteering to participate in clinical trials is our first priority, and our oversight of trial conduct is informed by trial sponsors efficiently notifying us of safety issues during the conduct of their trial. …
In this blog we describe ways to facilitate the review of your initial application, how to avoid unnecessary amendments and, where substantial amendments are necessary, how to submit these so that the review is as efficient as possible, leading to …
The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational …