The European Medicines Agency is inviting more drug sponsors to participate in a pilot it launched last year to reduce the time its regulatory reviewers spend on preparing assessment reports on initial marketing authorization applications (MAAs) by allowing companies to pre-fill these reports with factual data beforehand.
The approach is expected to free up more time for the MAA assessors to better focus on the drug assessment itself, and could potentially speed up regulatory reviews.
The EMA wants to learn whether the approach will give its assessors more time to “really think about the questions, potentially look more into the data and find the things...