EMA’s EUSTART explained: what the new pre-submission meeting means for your MAA
What does EUSTART mean for sponsors preparing an EU MAA? The new EU Submission, Timelines and Review Talk (EUSTART) aims to help applicants prepare for joint pre-submission meetings with EMA, rapporteurs and national competent authorities ahead of marketing authorisation applications (MAAs).
EMA’s ePI guidance for centralised procedures: what applicants need to know
What does EMA’s ePI guidance mean for sponsors submitting product information? Learn how you might be affected by the European Medicines Agency guidance for applicants submitting electronic product information (ePI) in centralised procedures.