Back to School
MHRA seizes opportunity to reshape expedited approval
Newly independent, MHRA leapfrogs FDA, EMA pathways by integrating regulatory, reimbursement throughout the process
Newly independent, MHRA leapfrogs FDA and EMA pathways by integrating regulatory and reimbursement throughout the process.
The U.K.’s exit from the EU has afforded its MHRA a fresh start in creating an expedited approval pathway that goes beyond what FDA or EMA can offer: integrating market access, clinical trial and real-world evidence organizations directly into the process through the Innovative Licensing and Access Pathway.
Since MHRA became an independent regulator following the U.K.’s departure from the EU on Jan. 1, 2021, the agency has created the next