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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
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.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Importing investigational medicinal products for use in clinical trials
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How investigators and sponsors should manage clinical trials during COVID-19
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.
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.
Advice for manufacturers of Class I medical devices for placing products on the UK market
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
How to conform with the legal requirements for placing medical devices on the market.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukaemia (AML).
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