MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions
In October 2020, the MHRA launched a 6-week consultation with stakeholders on the MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions. Following the consultation and an analysis of the responses received, the MHRA has published two guidance documents: MHRA Guidance on the use of Real-World Data in Clinical Studies to Support Regulatory Decisions, and MHRA Guideline on Randomised Controlled Trials using Real-World Data to Support Regulatory Decisions.
Read the news from Medicines and Healthcare products Regulatory Agency published on 16 December 2021.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (15 mars 2022). MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o5w9





