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Welcome to your May 2025 edition of MHRA News.
The essential industry newsletter where we update you on our most recent activities.
To keep hearing from us with future editions, register here.
 We continue to report consistent performance against agreed key performance indicators in our statutory functions: licence applications for innovative and established medicines, variations to licences, and manufacturing and distribution authorisations.
Our priority is to maintain performance to predictable and statutory timeframes. We will continue to publish monthly updates providing applicants with transparent information on expected timescales.
Our data for April 2025 show that 100% of clinical trials and investigations applications continue to be handled within statutory timescales. Combined Review approval time with the Health Research Authority is now at 60 days or less for all trials, with an average time for Combined Review determination (including questions raised) of 40 days in April.
All new national licence applications are being assessed within our target of 210 days: with an average timescale of 166 days in April.
More resources are now available to help clear scientific advice requests and we expect further signs of positive impact to be reported in our data for future months. We will sustain this effort over the coming months as part of our wider work to further develop and enhance our scientific advice services. Find out about our work to overhaul the Scientific Advice service at MHRA.
 We published our updated processes for national assessment procedure for medicines in April. Updated processes for national applications for medicines (innovative and established) are aimed at providing clarity, transparency and improved predictability.
Our webinar in May provided an overview of the updated guidance and includes additional information for innovative medicines around timings for a pathway to the first CHM meeting/RFI (request for information). It also covered how the quality of the dossier will influence timelines from that point and opportunities, including the use of Scientific Advice and Pre-submission Meetings, to aid applicants on this.
The webinar recording is now available.
 We have launched a consultation to seek feedback on a draft guideline to support sponsors who are considering the use of real-world data in external control arms in clinical trials for new medicines and medical devices.
The consultation is open until Monday 30 June 2025 and anyone interested in clinical trials in the UK is invited to respond.
Real-world data refers to information that is collected from patients during the course of their normal clinical care and can include electronic health records, disease and patient registries, and patient-reported outcomes data.
The guideline has been drafted with input from the Commission for Human Medicines’ real-world data group and complements existing guidance we previously sought views on. It is an example of the MHRA’s support for innovation in clinical trials and our drive to ensure the UK remains one of the best places in the world for clinical research.
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A Statutory Instrument came into effect on 24 May, retaining four pieces of EU law that were due to expire, ensuring that regulations 4H, 4J, 4K, and 4L of the Medical Devices Regulations 2002 continue to apply until replaced at a later date. These retained regulations cover technical requirements for certain in vitro diagnostic devices, electronic instructions for use, medical devices manufactured using tissue of animal origin, and the designation and supervision of approved bodies. This decision follows a consultation where the majority of respondents favour retention to avoid a gap in regulation that could impact patient safety. For more information, see Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices - GOV.UK
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This month we published new guidance to help medical device manufacturers prepare for changes to reporting requirements for serious safety incidents and field safety corrective actions in Great Britain (GB). The new implementation guide for our Manufacturers Online Reporting Environment (MORE) clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025.
We are excited to announce the second webinar about our new world-leading regulatory framework for the manufacture of innovative medicines, near to or at the point of patient care. Registration has opened this week, and we encourage anyone interested to sign up.
On 17 June, we will be hosting the MHRA webinar on Decentralised Manufacturing Regulations Update from 14:00 - 15:30 (BST). This second webinar about our new, world-leading regulatory framework for the manufacture of innovative medicines near or at the point of patient care since the first session in January. In this vital, update we will provide further information on the Decentralised Manufacture (DM) hub, guidance changes, and illustrative examples of anticipated treatments. Additionally, we are working with international regulators to develop strategies to help support innovators even further. For queries, email conferences@mhra.gov.uk.
On 19 June, we will hold the next AI Airlock webinar. This informative event will provide an update on the AI Airlock pilot program, including a summary of pilot projects, early insights, and lessons learned. We will also discuss the second phase, key focus areas, and application information. Please register your attendance and help us promote these events via the newsletter to reach a wider audience.
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 Windsor Framework for human medicines was successfully implemented on 1 January 2025.
Marketing authorisation holders working in the pharmaceutical industry need to be aware that the ‘UK Only’ statement can only be applied to medicines via a sticker until 30 June 2025. After this date ‘UK Only’ must be printed directly onto packaging.
Guidance on labelling and packaging can be found on our website
Please email questions about labelling to patient.information@mhra.gov.uk
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.
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