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Welcome to your December 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.
New Clinical Trials legislation was laid in Parliament on 12 December 2024 that will address the research sector's need for a more efficient, streamlined and adaptable regulatory framework for clinical trials.
As the biggest overhaul of clinical trials regulations in 20 years, these reforms will make the UK a more attractive place for innovators to conduct important research and will help to get potentially life-changing new treatments to patients and the NHS as quickly as possible.
Once made into law, the new legislation will come into force following a 12-month implementation period to ensure readiness. These changes are being introduced with support from health system partners including the Health Research Authority (HRA), academia and researchers.
Read more in the MHRA’s press release: Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today.
The latest MHRA performance data shows 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).
The latest MHRA 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 13 days (within the statutory timescale of 30 days).
For established medicines, we eliminated our original backlog of national marketing authorisation applications and continue to assess all new applications within expected timescales.
Year to date performance of International Recognition Procedure applications has seen 96% of all applications processed within the expected timescales.
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.
The MHRA’s pipeline and portfolio gathering process was launched in August. 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.
At the end of November, the MHRA was pleased to announce that the vast majority of companies had already submitted ‘UK only’ labelling artwork before the 31 December 2024 deadline to ensure compliance with the new arrangements for medicines under the Windsor Framework.
From 1 January 2025, the MHRA will be responsible for licensing all medicines on the market in Northern Ireland under a UK-wide licence, and all medicines for the UK market must carry a ‘UK Only’ label or sticker to show that they are only for sale within the UK and not in countries inside the European Union (EU).
Supporting materials including guidance on labelling and packaging for medicines is available on our Windsor Framework Hub.
Marketing authorisation holders with any concerns around implementation should contact partnerships@mhra.gov.uk.
General questions about labelling requirements should be emailed to patient.informtion@mhra.gov.uk.
See guidance for the labelling and packaging of medicinal products for human use following agreement of the Windsor Framework
MHRA webinar on the progress of the UK's new regulatory framework on point of care and modular manufacturing. Tuesday 28 January 2025 14:00 – 15:30 (GMT).
On 28 January 2025, the MHRA are holding a webinar to provide in-depth look at the UK’s new regulatory framework for point of care and modular manufacturing. It will cover key changes to UK legislation, including updates to The Human Medicines Regulations and Clinical Trial Regulations, as well as proposals for technical guidance on GxP inspections, clinical trials, and marketing authorisations. The session will also highlight international regulatory efforts in this area. Sign up for the webinar here.
The MHRA's pioneering framework enables the production of highly personalised medicines in or near hospitals, facilitating faster, safer access to innovative treatments. The legislative change, laid before Parliament on 21 October 2024, aims to streamline the manufacture of medicines with short shelf lives and supports modular production, particularly for pandemic responses.
Five innovative technologies have been selected by MHRA for the AI Airlock, a pilot scheme to better understand how we can regulate artificial intelligence (AI) powered medical devices in a way that that enables getting these types of products to the NHS and patients who need them as quickly and safely as possible.
The findings from the pilot, due to be announced in 2025, will inform future AI Airlock projects and influence future UK AI Medical Device guidance. For example, the findings are likely to influence how we work with UK Approved Bodies on UKCA marking and improve the framework of support for manufacturers developing these types of products.
The MHRA has approved the medicine delgocitinib (Anzupgo) to treat moderate to severe chronic hand eczema in adults when topical corticosteroids are inadequate or inappropriate. Anzupgo contains the active substance delgocitinib, which belongs to a group of medicines called Janus kinase inhibitors.
The MHRA has approved the medicine flortaucipir (Tauvid), a radiopharmaceutical product given to adults with memory problems so that doctors can perform a type of brain scan called a PET (Positron Emission Tomography) scan. Along with other brain function tests, flortaucipir may help the patient’s doctor find the reason for their patient’s memory problems by helping to determine whether they have abnormal forms of tau protein in their brain.
We are seeking views on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. Submit your responses and read more about the consultation here. The MHRA welcomes views from all interested stakeholders.
This consultation closes at 11:59pm on 5 January 2025.
The consultation seeks views on the following areas:
- UKCA marking
- International Reliance
- In Vitro Diagnostic (IVD) devices
- Assimilated EU law
On 11 December 2024, the MHRA published a revised Roadmap towards the future regulatory framework for medical devices. This provides a further update on the intended timelines to implement the future medical device regulations.
The MHRA also published the latest blog from Laura Squire OBE, our Med Tech Regulatory Reform Lead and Chief Healthcare, Quality and Access Officer. Laura reflects on the past year and looks forward to the opportunities to engage with us on emerging priorities and policies.
Ahead of the festive season, the MHRA has issued six top tips to help people stay healthy and safe through the festive season and beyond. From coughs and sneezes to mental health apps, these tips aim to help people stay safe during the festive season and beyond.
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