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How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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.
How to use a cost effectiveness analysis to evaluate your digital health product.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The Department has issued guidance on the use of the prescribing Better Care Better Value Indicators, especially in relation to the indicator for statins.
Data on the real-world efficacy of the COVID-19 vaccines.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
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