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How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
The MHRA is ready to provide any assistance for clinical trials applications submitted for 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.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak.
Actions that trial sponsors should consider to build resilience into clinical trial design
How investigators and sponsors should manage clinical trials during COVID-19
Chief Medical Officer for England, Professor Chris Whitty's annual reports and lectures on medicine and public health.
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