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 …
A lot has happened in the month since my last blog, including the launch of the national conversation about the NHS and Budget announcement of additional funding for Life Sciences. This has highlighted the vital role of diagnostics and Med …
Our external engagement on the programme of regulatory changes for medical devices has re-started in earnest this week following the pre-election period and early discussions with new ministers. Bilateral meetings with Trade Associations have begun again, we are speaking at …
Last time I wrote was just before we headed to Washington DC for the 25th Session of the International Medical Device Regulators Forum (IMDRF), hosted by the US Food and Drug Administration (FDA). The first two days were a workshop …
The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the MHRA is changing. From 01 June 2024, ASRs such as the Development Safety Update Report (DSUR) will not be considered valid unless …
March 24th marks World TB Day, an important moment to recognise the global effort required to eliminate tuberculosis (TB), a disease that, despite being preventable and curable, continues to be a global health threat. TB does not discriminate, affecting individuals …
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 …
On 9 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) published its Roadmap for the delivery of the future regulatory framework for medical devices. In the first of a new blog series, Laura Squire, Med Tech Regulatory Reform …
World AMR Awareness Week (WAAW) is an annual global campaign from 18-24 November that raises awareness and understanding of antimicrobial resistance (AMR), a global health issue worsened by the misuse of antimicrobial agents such as antibiotics. AMR can lead to …
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 …