Current Regulations for Marketing Authorization and Procedure for Filing of Active Substance Master File (ASMF) in European Union: A Case Study

Abstract

Active Pharmaceutical Ingredient is an ingredient in a drug product that is biologically active. A Drug Product will contain two components, one is the Active Ingredient and the other is the Excipients part. Drug Product that has to be placed in the European market needs to have a marketing authorization. Marketing Authorization is the process in which the drug product is evaluated for its safety and compliance with the standards laid down by the Regulatory Authority, considering the safety of patients and public. There are different Procedures for the application of Marketing Authorization. Applicants can either apply for marketing authorization through centralized procedure, decentralized procedure, mutual recognition procedure or the nationalized procedure. Active Substance Master File (ASMF) is a Regulatory Dossier that helps provide confidential data pertaining to the Active Substance to the regulatory authority. This master file shall contain data from the research of the product to the development and lifecycle of the product. ASMF contains two parts, the restricted part and the open part. Both of these parts of ASMF shall not be shared to anyone without a written consent from the ASMF Holder. This master file makes it easy for the application of any Marketing authorization and also makes it easy for the regulators to access all the required data. European Union thus has laid down many Regulations and guidelines for the application of Marketing Authorization and also on how an ASMF is filed in European Union. The current work aims at methodically analyzing the guidance documents that are available and thus help in the review of regulations for the application of Marketing Authorization and also in knowing the process for the filing of Active Substance Master File (ASMF) in the European Market.