Welcome to the March issue of the Med Tech Regulatory Reform blog series. As the leader of a team which includes many talented female scientists, I am particularly delighted to be publishing this at the start of British Science …
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 …
There can be a degree of uncertainty when it comes to writing and formatting an expert report. Companies will often ask questions such as: What is expected from the expert report? Is there a minimum qualification/requirement for acting as a …
This is the third blog in this series on novel trials, following an initial update on clinical trials and a second on a survey that was launched in December 2019. The survey is now closed, and thank you to everyone …
Physiological changes in a woman’s body during pregnancy can change how quickly a medicine is distributed and eliminated from her body. This can affect plasma drug levels and how well a medicine works. Understanding how and when these changes occur …