An Active Substance Master File (ASMF) is a confidential set of documents that provide detailed information on the manufacturing, quality, and safety of a drug substance. Outside of the EU, an ASMF is known as a DMF (Drug Master File).
An ASMF is divided into two parts:
- The Restricted Part – Contains confidential, proprietary details about manufacturing, quality control, and processes. This section is submitted directly by the ASMF holder to regulatory agencies.
- The Applicant’s Part – Includes non-confidential information that the drug product applicant can use for their regulatory submission.
The ASMF system does not apply to biological medicinal products due to their complexity. Unlike small-molecule drugs, biologics are derived from living cells and require intricate manufacturing processes. Their quality assessment involves not just physico-chemical and biological testing but also a deep understanding of the manufacturing process and its controls.
Because of this complexity, biological medicinal product applicants must have full access to all quality data to take full responsibility for their product. Since an ASMF restricts access to critical data, it is generally not permitted for biologically active substances.
However, for organic substances isolated from animal or human origin special considerations apply. According to guidance by the CHMP (Committee for Medicinal Products for Human Use), information about these biological substances may either be submitted as part of the MAH dossier, or via an ASMF procedure.
If you would like to know more about ASMFs or how Starodub can assist your projects, please reach out to us via Contact form.
