The AI Airlock is a pilot programme designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively. Since we announced the pilot cohort in early December, the AI Airlock …
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 global fight to eradicate polio is one of the most successful public health stories in recent years. Polio was once one of the most feared childhood illnesses in the world. It can be contracted at any age, but it …
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 …
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 Medicines and Healthcare products Regulatory Agency is playing a fundamental role helping to ensure that the UK remains one of the best places in the world to deliver safe, cutting-edge research. Part of this work is the recently-launched combined …
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 …
My last blog on 'variations' looked at the importance of choosing the right change code, as there are about 350 in total. It can also be tricky choosing the correct procedure, whether that’s minor (Type IA and Type IB) or …