BIA response to MHRA rare disease therapies consultation

The MHRA has consulted on proposals for a new regulatory framework for rare disease therapies. The draft framework is available here. 

The BIA strongly welcomes the MHRA’s leadership in developing a new regulatory framework for rare disease therapies. We agree that the UK has the foundations to be a global leader in rare disease innovation and the new framework provides an opportunity to cement this. In order to fully deliver on this ambition, we recommend several improvements to ensure the framework is practical, attractive to developers, and capable of delivering patient access.