Challenges in implementing findings of regulatory science to evaluate and improve the drug regulatory system

Abstract

Background: Several initiatives have been undertaken to evaluate and improve the functioning of various aspects of the drug regulatory system, including pharmacovigilance. In an era of rapid decision cycles, the next challenge is how and when to rapidly implement the findings and assess their impact. There is a need to identify which/when results are matured enough to form a basis to implement changes in clinical practice and decision-making. Objectives: To present challenges faced by regulators, industry and researchers in transferring results of regulatory science projects into practice and discuss the dilemma between the needs for prompt action and scientific validation.