Update on the status of the adaptive pathways pilot project at EMA

By William Chin, PhD, Scientific Coordinator, EUCRAF

Out of 34 requests for dossiers assessement through the adaptive pathways, only 6 medicines were selected to go forward into the next stage of assessment. EMA will have a in-depth discussions with the company together with health-technology-assessment (HTA) bodies and patients’ representatives. EMA launched the adaptive pathways pilot project in March 2014 to improve faster access of new medicines to patients. The scope of adaptive pathways is the granting of early approval of medicines for a well-defined, high medical need subgroup of patient populations followed by a commitment for post-approval data collection. According to EMA, the full review of the outcome and impact of the adaptive pathways pilot project will be conducted once at least six medicines selected for the pilot have completed a procedure of parallel scientific advice with HTA bodies. 


1. EMA News, 22 December 2014, Status of the adaptive pathways pilot project