1. Common facilitating practices in facilitated regulatory pathways*
Facilitated regulatory pathways (FRPs) can accelerate access to important new medicines and sponsors of products that may fulfil unmet, serious public health challenges should interact early with national regulatory authorities (NRAs) to address current requirements.
While the characteristics of FRPs used by stringent regulatory authorities have been well characterised, no systematic assessment has been conducted of these characteristics for emerging.
This study assessed 33FRPs in emerging NRAs from 29 countries to understand their diversity and similarities, noting how often FRPs addressed a characteristic, the most common assessment for each characteristic and the number and distribution of characteristics. This slide provides a summary of the most frequently observed characteristics.
Agencies from the Middle East/North Africa and Eastern Europe addressed the most (median, 17) characteristics of FRPs in their public documentation.
All FRPs addressed at least twice as many procedural characteristics.
A majority of FRPs provided opportunities for frequent interactions between sponsor and agency review teams.
Observed diversity in regional FRP characteristics suggests a role for further engagement with emerging NRAs in their design and implementation.
These results and further research and experience may suggest FRP characteristics that could be successfully implemented by emerging NRAs.
From Liberti L et al. J Pub Health Pol Mar 10. doi: /jphp
From Liberti L et al. J Pub Health Pol Mar 10. doi: /jphp