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The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.
The authors of this review sought to identify every study where people with an abdominal injury were randomised to surgery or observation
How to use a combination of quantitative and qualitative data to evaluate your digital health product.
Some of the leading minds from across the world of science have given their backing to Professor Mark Thomson’s bid to be the next Director-General of CERN.
Tell DVLA you've had an operation if you're still unable to drive 3 months after the surgery
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
How to confirm a measles diagnosis, manage cases and contacts, control infection, and vaccinate young or partially-covered patients.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
How the MHRA processes variations to Marketing Authorisations (MAs)
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information and guidance on a range of medical devices for users and patients.
Information on taking, submitting and processing samples which potentially contain monkeypox virus.
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.
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