Data: The Future Of Regulatory Info Management In Europe

By Frits Stulp and Aida Demneri

During the pandemic, it became clear that the time to get a product approved and to market is too long and protracted in the EU. Although extraordinary measures were taken during the past two years so that vaccines and critical medicines could be brought safely to market at greater speed, this was achieved largely by extending the working hours of assessors. Now that market expectations have been raised, there is a new sense of urgency for the EC (European Community) and EMA around transforming approval processes more permanently and sustainably.