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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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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Statutory guidance: MHRA fees
Fees payable to the MHRA from 2025.
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MHRA CEO Lawrence Tallon welcomes Life Sciences Sector Plan
The Life Sciences Sector plan was released today (16 July 2025)
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Clinical investigations for medical devices
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema (HAE) attacks in patients aged 12 and over
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 15 July 2025, approved sebetralstat (Ekterly) for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.
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Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden
The specifications will establish standards for high-risk diagnostic tests while creating consistency with European regulations
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Common specification requirements for in vitro diagnostic devices
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
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Don’t let the heatwave affect your medicines: Three important tips from the MHRA
Essential advice on protecting your medicines during extreme heat and staying safe this summer.
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MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.