By Anthony Carter – MHRA Low-Risk Assessor Manager, Clinical Investigations & Trials Operations Team September 2025: This blog provides information about the Route B substantial modifications and why you should sign up to take part in the pilot if you …
To celebrate British Science Week, we spoke to the MHRA’s Deputy Director of Innovative Medicines, Shirley Hopper, to see how new medicines are approved. Q: What is your role at the MHRA? I’m Shirley Hopper, a medical doctor by …
International Women’s Day: Inspire Inclusion It’s International Women’s Day and Mandy Budwal-Jagait, Head of our Good Clinical Practice (GCP), team discusses why it’s important for us to Inspire Inclusion in the workplace. Trust, representation, opportunity, understanding, belonging. These are just …
Dr Alison Cave, Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) highlights how genetics could play an important role in minimising the risk of adverse drug reactions (ADRs), and how the MHRA are working with partners …
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 …
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, …
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 …
Administrative changes can be either Type 1A or Type 1B and are considered minor variations. These include company name, postcode and/or address changes, the removal of redundant sites, and drug substance name changes. Additionally, changes can include ‘Quality Review of …