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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.
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.
Actions that trial sponsors should consider to build resilience into clinical trial design
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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.
How to use a multiphase optimisation strategy (MOST) to evaluate your digital health product.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
This study assessed the care of hypertension, diabetes and HIV patients in Medication Adherence Clubs in Kibera, Nairobi
This systematic review is the first to describe the evidence base for MSSS models of care and highlight the current limitations of available research.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to use a factorial randomised controlled trial to evaluate your digital health product.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
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