Active Substance Master File (ASMF) Submissions – Overview
An Active Substance Master File (ASMF), formerly known as a European Drug Master File (EDMF), is not mandatory for European Union (EU) Health Authorities (HAs) but is reviewed in connection with a Marketing Authorization Application (MAA). API manufacturers or ASMF holders can submit ASMFs directly to the EU HAs, following the procedures defined by the MAA holder.
To avoid administrative delays or rejection of an MAA due to a missing ASMF, timely submission in compliance with EU-specific ASMF guidelines is critical. An ASMF holder can provide a Letter of Authorization (LoA) to multiple MAA holders for reference across multiple applications.
X Pharma Plus possesses extensive expertise in handling ASMF submissions and managing their lifecycle, ensuring compliance and smooth MAA approval processes.
Active Substance Master File (ASMF) Submissions
“Ensures consistent active substance quality across applications while protecting confidential manufacturing information submitted to EU authorities.”