ARTICLE | Regulation

MHRA seizes opportunity to reshape expedited approval

Newly independent, MHRA leapfrogs FDA, EMA pathways by integrating regulatory, reimbursement throughout the process

September 2, 2021 1:10 PM UTC

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 evolution of an expedited approval pathway by replicating, and then building on, the pathways it had become so familiar with at EMA. These include conditional marketing authorization (CMA) of products with less comprehensive data but an expectation to provide more postmarket; and approval under exceptional circumstances, where the collection of comprehensive data is considered either unreasonable or unethical. Under MHRA, both pathways have the same eligibility criteria as EMA’s pathways...

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