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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.
This page provides details of the efficacy and toxicity tests oil spill treatment products (OSTPs) must pass before being approved for use in UK waters, including information on the associated fees and methods for payment.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on using non-investigational medicinal products in a clinical trial.
How to use usability testing to evaluate your digital health product.
Guidance on choosing evaluation study types and methods.
Find out how to take samples from processed ABPs and find laboratories to test them, and what to do if one of your samples fails a test.
Information on comparator products used in studies supporting abridged marketing authorisation application.
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