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These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Check what side effects people have reported when they have taken a medicine.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
The review of the safety of isotretinoin has concluded.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Oct - 31 Dec 2023.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
Guidance on using non-investigational medicinal products in a clinical trial.
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
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