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Welcome to your January 2025 edition of MHRA News.
The essential industry newsletter where we update you on our most recent activities.
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Professor Anthony Harnden has officially started his role as Chair of the Medicines and Healthcare products Regulatory Agency (MHRA).
In his first 100 days, Anthony’s priority will be talking and listening to staff and partner organisations so he can gain a strong understanding of how to drive forward the strategic direction of the MHRA to maintain the UK as a global centre of excellence in life sciences, in the best interests of patients and the public.
At the beginning of the month Anthony recorded a short introduction video and highlighted his ambitions for his first 100 days.
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Our performance data show that clinical trials and investigations applications continue to be handled within statutory timescales.
Regulatory assessments for clinical trials have been completed in an average of 28 days for initial assessments (within the statutory timescale of 30 days) and an average of 29 days for assessments of amendments (within the statutory timescale of 35 days).
 Our latest performance data show that we continue to make significant steps towards assessing applications for all medicines approvals within statutory timescales.
This month for variations, regulatory assessments for all Type 1a variations submitted over the last month have been completed in an average of 18 days (within the statutory timescale of 30 days).
For established medicines, we eliminated our original backlog of national marketing authorisation applications and continue to make significant progress towards eliminating the remaining overdue applications, with a focus on completing assessments. We are now assessing all new licence applications for established medicines within expected timescales. Regulatory assessments for International Recognition Procedure (IRP) applications are being completed within statutory timeframes.
Our prioritisation strategy ensures that applications are taken in order of validation date, except for applications for products that can meet public health needs, for example to prevent shortages or first generic products.
Through the MHRA’s pipeline and portfolio gathering process we encourage all current and future Market Authorisation Holders for medicines to provide information on planned or potential future submissions. This allows us to plan our resource, resulting in applications being assessed with scientific rigour and within predictable timeframes.
The Windsor Framework (WF) arrangements for medicines came into effect on 1 January 2025, introducing UK-wide licensing. This means that medicines we approve and license on a UK-wide basis will be supplied in the same packs across the whole UK.
95% of companies submitted updated artwork by the 31 December 2024 deadline. Any Market Authorisation Holders (MAHs) who need support regarding the implementation of the new arrangements should contact us at partnerships@mhra.gov.uk. We have supported several companies to reach a compliant pathway.
Visit the WF Hub for guidance and supporting materials for industry. It also includes information about the main changes that healthcare professionals, particularly pharmacists and prescribers, need to be aware of.
Innovate UK – the UK’s innovation agency, in partnership with the MHRA, Office for Life Sciences, and the Medical Research Council have this week announced seven Centres of Excellence for Regulatory Science and Innovation (CERSIs).
The projects, led by academic institutions, independent innovators, or regulatory leaders forming collaborative partnerships, will receive funding up to £1 million each, to lead the way in safer, faster pathways for innovative medicines and devices.
Read more about this on the UKRI website
The new Innovative Licensing and Access Pathway (ILAP) focussed on getting the most transformative new medicines to patients in the National Health Service (NHS) more quickly has just been launched. Find out what’s on offer, the new eligibility and selection criteria, enhanced services and how to apply from 31 March 2025, by viewing the ILAP guidance. More details on our March 2025 webinar coming soon.
On 13 January we launched our pilot of Real-World Evidence Scientific Dialogue Programme in line with our Data Strategy, which is designed to support innovators with their evidence generation strategies and to clarify regulatory and health technology assessment expectations for real-world evidence throughout a medicinal product’s lifecycle.
The programme aims to facilitate our discussions with applicants, with a specific strategic focus on real-world evidence. This is offered through either a closed-door meeting for commercially sensitive discussions and/or admittance to a pre-competitive, ‘safe harbour’ workshop jointly convened by The National Institute for Health and Care Excellence (NICE). Expressions of interest will be accepted from 10 February 2025.
The MHRA has adopted the ICH M13A Guideline on bioequivalence (BE) studies.
ICH Guidelines which have been adopted by the MHRA are listed in the MHRA directory of ICH Guidelines.
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As part of the crackdown on criminal profits, more than 17 million doses of illegally traded medicines, with a potential street value of more than £40 million, were taken out of circulation last year alongside our enforcement partners. These included painkillers, sleeping tablets and erectile dysfunction treatments. |
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