All MHRA articles
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JournalMD7: Updates on Artificial Intelligence legislation and policy
This is a report of the MD7 session that took place at this year’s Symposium.
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JournalMD3/IVD3: A global snapshot – Non-EU regulatory updates for medical devices and IVDs
This is a report of the MD3/IVD3 session that took place at this year’s Symposium.
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Industry newsMHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
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Industry newsMHRA cross-agency team outlines emerging considerations for the manufacture of personalised medicines
This industry news update shares the MHRA’s guidance for the manufacture of personalised medicines.
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Industry newsAI Airlock: Growing the future of artificial intelligence technology in healthcare
This industry news update is about the ongoing projects as a part of AI Airlock led by the MHRA.
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Industry newsNICE rejects funding for Lecanemab as treatment benefits ‘remain too small’
The National Institute for Health and Care Excellence (NICE) has recently announced that it will not back funding for the Lecanemab due to concerns about its effectiveness.
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Industry newsUpdated post-market surveillance requirements take effect
This industry news update looks at the MHRA’s new PMS requirements for medical devices that took effect on 16 June 2025.
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Industry newsMHRA authorises new cancer treatment variation with significantly reduced administration time
On 30 April 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) authorised a new under-the-skin injection variation of nivolumab (OPDIVO). This offers a quicker administration of the treatment for eligible patients.
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Industry newsMHRA provides guidance to streamline safety communication
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on safety communications to ensure that medicines, medical devices and other healthcare products reach ‘high standards of safety, quality and efficacy.’
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Industry newsMHRA appoints new Chief Executive Officer
Lawrence Tallon has been appointed the new Chief Executive Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) and will begin the role on 1 April 2025.
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Industry newsMHRA approves Nemolizumab for eczema patients in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nemolizumab, also known as Nemluvio, to help with the treatment of atopic dermatitis (eczema) in the UK.
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Industry newsGreater post-market surveillance for medical devices
New draft legislation was laid before the UK Parliament on 21 October 2024 which would require greater post-market surveillance (PMS) for medical devices on the market in Great Britain.
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Industry newsMHRA publishes ‘recognition route’ revised guidance
The MHRA has issued guidance on its International Recognition Procedure, which will replace the EC Decision Reliance Procedure from January 2024.
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Industry newsMHRA plans medical device technologies streamlined pathway
UK agency aims to make route-to-market much more straightforward for manufacturers with Innovative Devices Access Pathway.
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Industry newsMHRA seals deal for fast international recognition routes
UK agency adopts recognition routes from seven national authorities; new signals start of new international framework for medicines.
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Industry newsMHRA reappoints two non-exec directors
Two Non-Executive Directors have been reappointed to the MHRA Board effective from September 1, 2023, according to the Department of Health and Social Care.
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JournalEvolutions in patient healthcare at MHRA
Chief Safety Officer, Alison Cave discusses her role at the MHRA, key objectives and ambitions for the regulator.
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FocusBrexit − Regulatory and supply chain considerations
The UK formally left the EU on 31 January 2020 and the transition period, as set out in the withdrawal agreement, came to an end on 31 December 2020. During this transition period, the UK continued to remain under EU pharmaceutical law. From 1 January 2021, the UK adopted an ...
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FocusPharmacovigilance regulations post-Brexit
The UK (Great Britain and Northern Ireland) has left the EU and the Brexit transition period has passed. This article covers points to consider when ensuring that pharmacovigilance systems for human medicinal products are compliant with EU and UK requirements. The UK requirements largely mirror the existing EU pharmacovigilance (PV) ...