EMA Mandates Web-Based Electronic Application Forms for Centrally Authorized Products

The European Medicines Agency (EMA) has made the use of the PLM web-based electronic Application Form (eAF) mandatory for all Centrally Authorized Products (CAPs) as of September 1, 2026. This regulatory action aims to enhance the efficiency, accuracy, and consistency of regulatory submissions by enabling automated data processing and seamless integration with other EMA systems. Submissions for human CAP variations using the interactive PDF eAF will be rejected from this date unless a valid technical reason prevents the use of the web-based version.