Active Substance Master File also known as European Drug Master File allows the protection of confidential information regarding the ” know-how of the active substance manufacturer”. While protecting the intellectual property information ASMF equips the Applicant or Marketing Authorization (MA) holders to Assume accountability for the medicinal product, its quality, and quality control of the active substance.

One can get detailed guidelines on ASMF submission procedures from EMA, but in this article, we are going to learn the overview of ASMF.

CONTENT OF ACTIVE SUBSTANCE MASTER FILE: The contents of the active substance master file are divided into two parts:

1. Applicants Part
2. Restricted Part

The applicant’s part contains information that the ASMF holders consider non-confidential, and in the Restricted part, the information contained is considered confidential by the ASMF holders. The restricted Part contains information regarding manufacturing steps in detail and the conditions of the reactions, temperature, quality control, etc.

The ASMF also contains information like a table of contents and a separate summary for the Applicant part and a restricted part.

ASMF Uses – It is used to submit information in support of MAA or MAV & used for following active substances including herbal active substances like New active substances, Existing active substances not included in the European Pharmacopoeia or the pharmacopoeia of an EU Member State& Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State.

ASMF Procedure is not used for Biologic API. and submission of ASMF for human use should be made in CTD format only.