EMA updates e-submission guidance in line with EU pharmacovigilance legislation
This article was originally published in SRA
The European Medicines Agency has updated its detailed guidance on electronic submission of information on human medicines to include the XML Schema Definition (XSD) that marketing authorisation holders can use to submit the data elements required1. The EMA, which says the update marks the second stage of implementing the EU pharmacovigilance legislation (Regulation (EC) No. 726/2004), has also published a set of controlled vocabularies to support the submission process.