BIA response to MHRA consultation on use of real-world data in external control arms
The MHRA has published a draft guideline on the use of external control arms (ECAs) based on real-world data (RWD) to support regulatory decisions. The consultation on the draft guideline closed on 14 July 2025.
We welcome the MHRA's initiative in developing this draft guideline. Our response to this consultation has been developed with input from members of the BIA’s Regulatory Affairs Advisory Committee (RAAC), and includes several points for consideration and suggestions on how the guidance could be improved.
