BioCentury
ARTICLE | Regulation

PRIME-ing the system

How EMA's PRIME could speed up patient access to breakthrough therapies

March 21, 2016 7:00 AM UTC

EMA's new PRIority MEdicines initiative aims to get breakthrough therapies to patients faster, but the program could make reimbursement by health technology assessment bodies more challenging if the therapies come to market with limited data.

EMA announced the PRIME program March 7 to expedite the development and review of molecules that demonstrate exceptional efficacy in early clinical trials. ...