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

Preparing a marketing authorisation application (MAA) requires early planning, clear communication, and a sufficiently mature dossier. To strengthen this process, the European Medicines Agency (EMA) has introduced a revised Guidance on the "Pre-Submission Interactions (PSI) model" as part of a voluntary pilot phase. The revised model aims to encourage earlier and more comprehensive dialogue between applicants, rapporteurs, and EMA. It focuses on improving submission readiness

As medicines move toward electronic formats, accurate and up-to-date product information is increasingly important. The European Medicines Agency (EMA) has issued guidance, "Electronic product information (ePI) submission during centralised procedures," explaining how applicants should submit, create, update, and maintain electronic product information (ePI) for centrally authorised medicinal products. The guidance provides practical instructions for managing ePI through the