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Funding of £85 million will be announced at a global event to support the international community in tackling the growing threat of antimicrobial resistance.
MHRA performance metrics for clinical trials and established medicines assessment.
Here we provide the MHRA performance data including timelines for…
Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by BModesto B.V.
Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
List of Field Safety Notices from 6 to 10 May 2024.
Marketing authorisations granted in 2024
Parallel import licences granted in 2024
List of Field Safety Notices from 29 April to 3 May 2024.
A list of authorised orphan medicinal products registered by the UK licensing authority.
The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.
Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.
List of sites granted a manufacturer or wholesale dealer licence
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human and veterinary).
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
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