Global Development Programme Research
Flexible Regulatory Pathways
As part of a CIRS doctoral research programme, eighty international participants from pharmaceutical companies, regulatory and health technology assessment agencies, patient advocates and academia were surveyed on their perceptions regarding the strengths and limitations of adaptive licensing and facilitated regulatory pathways.
Despite optimism regarding potential benefits, significant obstacles to implementation were recognised. Observations support the need to further detail the characteristics of these pathways and define and build on the elements of success to determine optimal approaches to implementation.
This research is fully described in Liberti L, Stolk P, McAuslane N, Somauroo A, Breckenridge AM, Leufkens H. Adaptive licensing and facilitated regulatory pathways: A survey of stakeholder perceptions. Clin Pharmacol Ther. 2015 [Epub ahead of print] PubMed PMID: 25877216.