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 …
On World Patient Safety Day, Holly Coole, registered mental health nurse and senior manager for digital mental health at the MHRA, discusses how the safety of medical products is monitored and how all nurses can help ensure potential issues are …
Shiva Ramroop, Medical Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA), and paediatric specialist, discusses how we ensure the safety of vaccines for children in the UK as new survey data reported by Meningitis Now shows the majority …
On this day in 1948, the United Nations (UN) came together to establish a global organisation that promotes health, keeps the world safe, and serves the vulnerable. Seven decades later, the World Health Organization (WHO) is celebrating its 75th …
I remember first hearing about the shared commitment to public involvement when it was announced. I was working in a research department of a hospital, experiencing first-hand how people’s lived experience could drive more inclusive and meaningful health and social …
Large Language Models (LLMs), including ChatGPT and Bard, offer great potential to mimic human conversation. LLMs only directed toward general purposes and whose developers make no claim that the software can be used for a medical purpose are unlikely to …
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 …