All Medicines and Healthcare Products Regulatory Agency (MHRA) articles
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Industry newsNew MHRA framework sets out IMA pathway for rare disease therapies
The MHRA has revealed its draft rare disease framework, open for consultation until 30 July. The current development model does not always suit the conditions for rare diseases as they require greater flexibility in how they are evaluated. The framework emphasises earlier engagement with regulators, flexible evidence requirements, ...
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Industry newsMHRA releases AI Airlock Phase 2 programme report
The AI Airlock Phase 2 Programme Report has been published by the MHRA, providing information on the insights and subsequent recommendations from Phase 2 of the initiative.
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Industry newsThe National Commission into the Regulation of AI in Healthcare releases survey findings
A summary of the findings from the UK National Commission into the Regulation of Artificial Intelligence in Healthcare’s Call for Evidence has been published, which highlights the need for a significant overhaul of the current framework.
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ContentsRegulatory Rapporteur June 2026 – Contents
The June issue of Regulatory Rapporteur focuses on lifecycle management.
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EditorialLifecycle management: Enhancing regulatory agility
Navigating complex regulatory requirements across multiple regions and dealing with fragmented data are common challenges for keeping marketing authorisations and technical files compliant. This June issue of Regulatory Rapporteur looks at how AI and advanced digital technologies can help by integrating data and generating predictive insights, enabling more proactive lifecycle management and time for innovation.
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JournalNavigating divergence: Practical lessons from the UK lifecycle management of licences
Four case studies demonstrate how marketing authorisation holders can optimise UK lifecycle strategy through the strategic use of national routes, the International Recognition Procedure and parallel submissions, despite increasing EU-UK regulatory divergence.
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Industry newsMHRA publishes draft 2026 medical device regulations for GB market
Regulatory pathways for medical devices in Great Britain are set for further change, following the publication of new pre-market requirements by the Medicines and Healthcare products Regulatory Agency (MHRA). The proposals introduce new measures on reliance, traceability and classification as part of the evolving post-Brexit regulatory framework.
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Industry newsMHRA seeks views on indefinite acceptance of CE-marked medical devices
This industry news update summarises the MHRA proposals for indefinite recognition of CE-marked medical devices in Great Britain and the potential impact for health systems and patients.
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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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JournalSandbox of trust: Regulated AI for health promotion and disease prevention
This article explores the capacity and potential for AI tools in analysing health data and helping with disease prevention.
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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 newsNew cancer drug approved by MHRA
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new drug for non-small cell lung cancer (NSCLC) via a national procedure.
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Industry newsNICE and EMA say new Alzheimer’s drug is ‘not recommended’
The new draft guidance from NICE states that Lecanemab is ‘not recommended’ and the EMA has recommended the refusal of the marketing authorisation for Leqembi.
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Industry newsMHRA reclassifies codeine linctus as prescription-only
Over-the-counter cough syrups which contain the opioid codeine have been reclassified as prescription-only medicines due to the risk of abuse.
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Industry newsMHRA workplan to support safe access to medtech
The MHRA has published a two-year workplan which will see the introduction of a range of new regulations for medical devices in the UK.
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Industry newsMHRA’s IRP pathway now open for new medicines approvals
Medicines manufacturers can now submit marketing authorisation applications via the MHRA’s International Recognition Procedure.