|
Welcome to your March 2025 edition of MHRA News.
The essential industry newsletter where we update you on our most recent activities.
This month we would like to hear from you. Complete our short three question survey and help shape the future of the MHRA News.
To keep hearing from us with future editions, register here.
We have published the MHRA performance data for February 2025. We have expanded our monthly reporting as part of our commitment to optimising service delivery and give applicants clear insights into current expected processing times.
We will now publish data across all 8 of our key performance indicators, and include further information about timelines across inspections, batch release and safety signals.
Our 2024/25 business plan gave a commitment to our focus being the optimisation of our service delivery for customers. It introduced key performance indicators and a corporate objective to enhance the transparency and accessibility of our performance data.
You can access the full performance data on the MHRA website.
In January, we launched our pilot Real-World Evidence (RWE) Scientific Dialogue Programme, which is designed to help innovators refine their evidence generation strategies while providing clear guidance on regulatory expectations. Expressions of interest are still being accepted until 11.59pm BST 4 April 2025; with guidance and forms are available on our website.
We have published a new web page for information about The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, which come into effect on 23 July 2025.
This hub will be the central repository for all information regarding the new regulations. A recording of the webinar held earlier this year is now available, and stakeholders can register on the hub to receive automatic updates when new information is posted.
We are now finalising guidance, following a workshop with industry, academia and health leaders earlier this month, where we gathered valuable input to ensure our guidance is clear and practical.
The new regulation will ensure the UK is the first country in the world to enable the safe development and supply of innovative, highly personalised medicines at the point of patient care
|
Our AI Airlock team brought together health sector and regulator partners with representatives from the four innovative companies selected for the AI Airlock pilot, at our AI Airlock Connect event, earlier this month.
Health Minister Baroness Merron opened proceedings with inspiring words about the opportunities of AI technologies in healthcare. We then gained valuable insights into the regulatory testing of each of the four AI medical device products going through the pilot. All this information and discussion will help us create guidance and support for companies bringing new and transformative AI technologies to the health system.
|
The MHRA was represented at IMDRF in Tokyo this month, to share learnings with international regulators on the work we are leading on AI and digital mental health technologies. And we gave updates about the regulatory changes we’re putting in place to protect patients and facilitate innovation, with the recent updates to the post-market surveillance regulations and guidance being the first step in our reform programme.
We joined panel discussions on the opportunities and challenges of international reliance – recognising approvals from other international regulators. And colleagues from our Wellcome-funded digital mental health technologies project led a workshop to encourage global alignment in how we regulate these emerging technologies for the benefit of patients.
In a UK-first, the Medicines and Healthcare products Regulatory Agency (MHRA) and Barts Health NHS Trust have developed a DNA sequencing approach that can be implemented onsite in hospitals so they can diagnose bacterial infections faster and more accurately.
This service will help doctors deliver better-targeted treatments earlier. For patients, this means a quicker recovery, fewer complications such as sepsis, and a reduced risk of spreading infections to others.
This technology is now being piloted to investigate and prevent hospital outbreaks caused by antibiotic-resistant ‘superbugs’ — a growing global threat.
|
We are pleased to announce the launch of our new monthly safety bulletin, the ‘MHRA Safety Roundup’, the latest step in a three-year Strategy for Improving Safety Communications to make medicines and medical device information clearer and more accessible for healthcare professionals.
On the 6 March 2025, we approved lazertinib (brand name Lazcluze) for adults with non-small cell lung cancer that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). It is to be used in combination with an approved cancer medicine called amivantamab.
You can write to us, email us or call us to get in touch with the MHRA. Find out how near the bottom of our homepage.
For any comments and feedback on this newsletter, please email: info@mhra.gov.uk.
To keep hearing from us with future editions, register here.
Stay connected
|
