Regulatory Blog

Preparing a marketing authorisation application (MAA) requires a sufficiently complete and mature dossier before submission. The European Medicines Agency (EMA) has developed the EU Submission, Timelines and Review Talk (EUSTART) to help applicants, rapporteurs, national competent authority (NCA) assessment teams, and EMA identify important issues before an application is submitted. EUSTART supports preparation for the joint pre-submission meeting (PSM), with the aim of facil