UK MHRA Medicines
Material regulatory developments from Medicines & Healthcare products Regulatory Agency are tracked daily by Cresthaven Analytics. Over the last 90 days, 20 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
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MHRA updates exceptional use authorisation register with new entries, extensions, and closures as of July 24, 2026
The MHRA published its weekly update to the exceptional use authorisation register on July 24, 2026, recording changes to the open and closed lists of medical devices approved for NHS and social care supply outside stand…
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MHRA issues Class 4 defect notification for Tuzulby prolonged-release chewable tablets over missing PIL and SmPC safety information
On July 23, 2026, the MHRA issued a Class 4 Medicines Defect Notification against Neuraxpharm UK Ltd covering specific batches of Tuzulby prolonged-release 20mg, 30mg, and 40mg chewable tablets. The defect concerns missi…
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MHRA mandates new domperidone contraindication for phaeochromocytoma patients across all UK product licences
The MHRA updated product information for all domperidone products on July 21, 2026, adding a contraindication for patients with confirmed or suspected phaeochromocytoma. The update responds to an identified risk of sever…
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MHRA grants first approval for lower-carbon propellant beclometasone inhalers, establishing a new product-class pathway for asthma therapeutics
On July 21, 2026, the MHRA approved the first beclometasone pressurised metered-dose inhalers using a next-generation lower-carbon propellant. The approval sets a regulatory precedent for this propellant technology acros…
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MHRA publishes Field Safety Notices issued between 13 and 17 July 2026 covering multiple medical devices
The MHRA published a consolidated list of Field Safety Notices issued between 13 and 17 July 2026. Users and distributors of the affected device classes are required to take action or conduct assessments.
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MHRA updates public register of suspended and revoked UK manufacturer and wholesaler licences for medicines and ingredients
The MHRA published an updated list on July 21, 2026 of UK companies whose licences or registrations to manufacture or wholesale medicines and active pharmaceutical ingredients have been suspended or revoked. The register…
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MHRA issues Class 4 defect notification for Xaggitin XL Prolonged-release Tablets over incorrect tablet counts in multiple batches
The MHRA published a Class 4 Medicines Defect Notification on July 20, 2026 after Macarthys Laboratories Ltd, trading as Martindale Pharma, self-reported incorrect tablet counts in bottles across several batches of Xaggi…
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MHRA publishes updated exceptional use authorisation register covering active, expired, and cancelled device exemptions
On July 17, 2026, the MHRA updated its public register of medical devices granted exceptional use authorisations. The register records manufacturers whose authorisations are active, expired, or cancelled under the UK's s…
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MHRA approves UK-donor plasma for five plasma-derived medicinal products, ending a longstanding supply restriction
On July 15, 2026, the MHRA approved UK-donor plasma for use in manufacturing five high-priority plasma-derived medicinal products. The decision reverses a supply restriction that had excluded UK-sourced plasma from domes…
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MHRA strengthens safety warnings across all botulinum toxin type A products following confirmed botulism cases
The MHRA issued updated safety warnings on July 15, 2026 for all botulinum toxin type A products after rare confirmed cases of botulism linked to their use. The action applies class-wide, covering all licensed products i…
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MHRA issues updated safety warnings for all botulinum toxin type A products covering iatrogenic botulism risk from toxin spread
On July 15, 2026, the MHRA published updated warnings for botulinum toxin type A products used in therapeutic and cosmetic settings. The warnings respond to confirmed cases of iatrogenic botulism caused by toxin spread b…
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MHRA publishes transitional arrangements guidance for the UK Clinical Trials Regulations affecting ongoing and new trial applications
The MHRA published guidance on July 15, 2026 setting out transitional arrangements for the UK Clinical Trials Regulations. The guidance establishes which procedural pathways apply to trials submitted or ongoing under the…
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MHRA publishes updated guidance on safety event reporting obligations for clinical trials of investigational medicinal products
The MHRA published updated guidance on July 15, 2026 on the collection, verification, and reporting of safety events in clinical trials of investigational medicinal products. The guidance sets out the procedural and docu…
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MHRA updates guidance on modifying clinical trial approvals under the UK clinical trials regulatory framework
The MHRA published updated guidance on July 15, 2026 on how sponsors must classify, submit, and assess modifications to an approved clinical trial. The guidance specifies the procedural categories that apply when amendin…
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MHRA publishes Field Safety Notices issued between 6 and 10 July 2026 covering multiple medical devices
The MHRA published on 14 July 2026 a consolidated listing of Field Safety Notices issued between 6 and 10 July 2026. The notices identify device-specific safety issues and required actions for healthcare providers and us…
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MHRA issues Class 2 recall of Becton Dickinson ChloraPrep 1mL applicators over sterility breach risk
The MHRA issued a Class 2 medicines recall on July 13, 2026 covering specified batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators distributed by Becton Dickinson UK Ltd. The trigger is a potential …
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MHRA issues Class 4 Medicines Defect Notification for Gabapentin Relonchem 50mg/ml Oral Solution following particle contamination reports
The MHRA issued a Class 4 Medicines Defect Notification on July 7, 2026 after Relonchem Limited reported visible particles inside some bottles of Gabapentin Relonchem 50mg/ml Oral Solution. The notification was triggered…
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MHRA approves UK-donor plasma for five high-priority plasma-derived medicinal products following safety review
The MHRA approved UK-donor plasma for five high-priority plasma-derived medicinal products on July 9, 2026. The decision follows a formal safety review and reverses the longstanding UK policy of excluding domestic plasma…
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MHRA publishes updated register of terminated and cancelled UK medicines manufacturing and wholesale dealer licences
The MHRA published its updated notice on July 10, 2026 listing UK companies whose licences to manufacture or wholesale medicines have been terminated or cancelled. The register is the authoritative public record of entit…
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MHRA publishes updated register of medical devices granted or lapsed exceptional use authorisations
The MHRA updated its public register of exceptional use authorisations on July 10, 2026, listing manufacturers whose devices have been granted, expired, or cancelled under the exceptional use pathway. The register reflec…
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