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 …
Today we honour clinical trial professionals globally and volunteers who take part in clinical research Clinical Trials Day is celebrated around the world to recognise the day that James Lind started what is often considered the first randomized clinical trial …
The UK has been leading the way in supporting and promoting transparency of clinical trials. Following our exit from the EU, the MHRA has been monitoring compliance with registration of trials of medicines in World Health Organisation recognised public databases, …
On 31 August 2021 we launched new systems functionality to support the combined review of Clinical Trials of Investigational Medicinal Products, or “CTIMPs”. For those unfamiliar, the combined review service (previously known as ‘combined ways of working’) offers a single …
If there was ever a day to reflect on the value of clinical research it is today. The past year has shown more than any other that, quite simply, clinical research saves lives. And UK clinical research has been at …
Last year we updated you on a pilot program to streamline the way clinical trials applications were reviewed in the UK. Working closely with colleagues in the Health Research Authority (HRA) and across the Devolved Administrations we jointly developed a …