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How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
The Department has issued guidance on the use of the prescribing Better Care Better Value Indicators, especially in relation to the indicator for statins.
How to use a cost effectiveness analysis to evaluate your digital health product.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
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