U.K. planning 'promising innovative medicine' designation
A spokesperson for the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) said the agency is developing a designation to allow early access to unlicensed products based on early clinical data. The "promising innovative medicine" (PIM) designation would be issued for drugs for life-threatening, chronic or seriously debilitating conditions after a scientific advice meeting to review the early data. The spokesperson said a PIM-designated product "may be promising as a possible candidate" for the early access to medicines (EAM) scheme, but declined to disclose if the designation would be linked to reimbursement.
EAM is a proposed program to allow for access to unapproved drugs based on Phase III data; reimbursement under EAM would be at the discretion of local NHS trusts. A November report published by MHRA said government discussions on the scheme were "ongoing" (see BioCentury Extra, July 17, 2012). ...