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Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
The scheme will see the lowest-risk clinical trials processed by the MHRA in less than 14 days.
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Final report of the independent review of UK commercial clinical trials, and government response.
Guidance on Animal Test Certificates (ATCs) required to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
This study assesses the practice of Reviews that included cluster-randomised controlled trials against criteria developed from guidance
This is a report on the main findings of the review and recommended actions.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
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