MHRA Real-World Evidence: knowledge and guidance

Supporting guidance, publications and resources on the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making for medicines and medical devices in the UK.

The Real-World Evidence Knowledge and Guidance Hub brings together Medicines and Healthcare products Regulatory Agency (MHRA) guidance, publications and resources relating to the use of RWD and RWE in regulatory decision-making in the UK. This hub is intended to provide a source of information for researchers, healthcare professionals, industry, patients and other stakeholders interested in the generation and use of RWE.

The MHRA defines RWD as data relating to patient health status or delivery of health care collected outside of a clinical study. When RWD are analysed, the information produced may be referred to as real-world evidence (RWE).