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Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information on comparator products used in studies supporting abridged marketing authorisation application.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on labelling for medicinal products used in clinical trials.
How to use a quasi-experimental study to evaluate your digital health product.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Lists of standards that businesses can use to show their products, services or processes comply with essential requirements of legislation.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
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