Posted by Michael Wonder on 25 Jun 2023
Use of real world evidence in regulatory decision making – EMA publishes review of its studies
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials.
Real world evidence can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent authorities.
However, more effort is needed to better anticipate the need for such studies and to speed up their initiation to ensure that regulators have access to RWE in a timely manner.
