“Breakthrough” Designation Another Harmonization Opportunity, Woodcock Says
An agreement with the European Medicines Agency likely would be necessary for therapies designated as breakthroughs to ensure expedited clinical program would be accepted in both jurisdictions.
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Drug companies looking for an FDA-style breakthrough therapies pathway in Europe shouldn’t hold their breath: the current European health care reimbursement landscape, regulators say, cannot support a breakthrough pathway.
Drug companies looking for a FDA-style Breakthrough Therapies pathway in Europe shouldn’t hold their breath: The current European health care reimbursement landscape, regulators say, cannot support a Breakthrough pathway. Europe is looking for other ways to shorten drug development times until the bigger-picture reimbursement question can be addressed. Is adaptive licensing the answer?
MHRA will not limit the number of drugs that could be awarded the designation, but the lengthy, expensive application process could effectively limit the number of small firms that can take advantage of it.