Quarterly Inactive Ingredient Database (IID) Change Log
Quarterly IID Change Log displays changes made since the previous quarterly IID publication.
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MHRA approves adrenaline nasal spray – the first needle-free emergency treatment for anaphylaxis in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 18 July 2025, approved adrenaline (epinephrine) nasal spray (EURneffy) to be used for the emergency treatment of serious allergic reactions, known as anaphylaxis.
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Guidance: CLOSED AI Airlock Phase 2 application
The call for applications for phase 2 of the AI Airlock is now closed.
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Mark J. Savant, M.D – 712306 – 06/26/2025
Clinical Investigator -
Early Alert: Microbore Extension Set Issue from B. Braun Medical Inc.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program -
Guidance: MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions
Points to consider when using real-world data in clinical studies
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Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
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Five non-executive directors reappointed to the Medicines and Healthcare products Regulatory Agency Board
Two board members have been reappointed for two years, while three others have had their term extended by a year.
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Chetak LLC Group Recalls Product Because of Possible Health Risk
Are recalling Frozen ‘Deep Sprouted Mat(Moth) 16 oz. and Deep Sprouted Moong 16oz. because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infection in young children, frail or elderly people and others with weakened immune system. -
Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery. -
Statutory guidance: MHRA fees
Fees payable to the MHRA from 2025.
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Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects
Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects