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Emergency Alerts Test on Sunday 7 September, 3pm
Upper Tribunal Administrative Appeals Chamber decision by Judge Butler on 3 July 2025.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
The Accelerated Access Review aims to speed up access to innovative drugs, devices and diagnostics for NHS patients.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
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.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Apply for an authorisation to manufacture extemporaneous preparations, autogenous vaccines, stem cell products or blood products for non-food animals.
This section of the SEPs Resource Hub provides an explanation of SEP specific words and terms used throughout the guidance.
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