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UK Perspective: MARA NICE and IDEAL Bruce CampbellNonExecutive Director Medicines and Healthcare products Regulatory Agency (MARA) Past Chair NICE Interventional Procedures and Medical Technologies
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UK perspective MHRA NICE refers to the regulatory framework and guidelines set by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) regarding the approval and assessment of medicines and healthcare products in the UK.
Manufacturers, sponsors, or developers of healthcare products and medicines are typically required to file under UK perspective MHRA NICE for regulatory approval and assessment.
To fill out UK perspective MHRA NICE, applicants need to complete specific forms provided by the MHRA, ensuring all relevant information about the product, including clinical data and health economic evaluations, is accurately provided.
The purpose of UK perspective MHRA NICE is to ensure that healthcare products and medications are safe, effective, and provide value for money before they are made available to the public.
Information required includes product details, clinical trial data, safety assessments, proposed pricing, and economic evaluations to assess the cost-effectiveness of the product.
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