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Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How investigators and sponsors should manage clinical trials during COVID-19
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Actions that trial sponsors should consider to build resilience into clinical trial design
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
How to use a randomised controlled trial to evaluate your digital health product.
How to use a quasi-experimental study to evaluate your digital health product.
How to use a crossover randomised controlled trial to evaluate your digital health product.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
Guidance on Animal Test Certificates (ATCs) required to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
How to use a before-and-after study to evaluate your digital health product.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
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