EMA study reveals need for RWE framework, submission structure


14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted.

Kurz, the head of surveillance and epidemiology at EMA, said the agency reached the conclusion after analysing the use of real world evidence in applications for marketing authorisation and extension of indication in 2018 and 2019. 

The study, preliminary findings from which were shared at RAPS Convergence 2021, found real world evidence was used in 40% of marketing authorisation applications, mainly at the post-approval stage, and in 18% of extension of indication filings.

Read Regulatory Affairs Professional Society article

Michael Wonder

Posted by:

Michael Wonder