Module 12 2019

Processing and validation • The eAFs should be provided as a part of the

submission package i.e. for eCTD submissions the eAF should be included inside the eCTD structure in Module 1 (folder 1.2/common) • Some NCAs are using the data of the eAF to populate their database – Missing overview of which NCAs use the data, which data and for which process

The Organisation for Professionals in Regulatory Affairs