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Urgent and clinically significant safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
The Accelerated Access Review aims to speed up access to innovative drugs, devices and diagnostics for NHS patients.
The AQuA Book is Government guidance about how to produce robust, fit for purpose analysis. It's for all analysts, analytical managers and commissioners.
Aival Evaluate reports the performance, fairness, robustness and explainability of AI products under consideration on a user’s data, enabling comparison along the same baseline.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
This section of the SEPs Resource Hub provides an explanation of SEP specific words and terms used throughout the guidance.
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