Giulia Corsi -

AIFA has recently published the updated procedures to be followed for the initial submission of an Active Substance Master File (ASMF) and any subsequent updates.

An ASMF, formerly known as European Drug Master File (EDMF), is a set of documents that contains all information on the manufacturing process, characterization and physicochemical properties, quality control procedures and requirements, and stability data of the active substance.

The purpose of an ASMF is either to protect the manufacturer’s confidential intellectual property or to provide health authorities (HA) with complete information on the active ingredient contained in a medicinal product for which a Marketing Authorization Application (MAA) is submitted.

From now on, the electronic Common Technical Document (eCTD) must be used to organise the content of the ASMF into modules, sections and documents. The submission of the dossier and subsequent updates must be performed through the Common European Submission Portal (CESP).

Regulatory Pharma Net (RPN) can fully manage the development of the CTD and eCTD dossier for all regulatory procedures and can support companies also in the preparation and submission of the eCTD ASMF dossier.

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