Drug Lag and Approval Time Metrics - Are They Good Markers to Assess the Global Regulatory Environment?

Time

Tue, Jun 16 9:00AM
T 19

Title

Drug Lag and Approval Time Metrics - Are They Good Markers to Assess the Global Regulatory Environment?

Abstract Summary

ORAL PRESENTATION SCHEDULED: Tuesday, June 16 in Session #1B at 12:03 - 12:08 pm Location: Exhibit Hall Poster Area (Hall A Entrance)

105 Approvals (2009-2013) in 17 EM markets were assessed along with time from 1st world submission to submission to EM and the timing of the CPP. Submission and approval for 371 NAS was also calculated for 6 MM. 15 NASs approved by both MM and BRICK-TM countries were analysed in more detail.

Poster Presenter

Magdalena Bujar
MSc,
Senior Research Analyst,
Centre For Innovation In Regulatory Science (CIRS)
United Kingdom