Active Substance Master File Procedure

The CHMP at EMEA published a revision of the QWP Guideline on Active Substance Master File (ASMF) procedure. The main objective of the Active Substance Master File procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or “know-how” of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or marketing authorisation (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance. Competent Authorities/EMEA thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product. This Guideline is intended to assist Applicants/MA holders in the compilation of the active substance section of their dossiers for a marketing authorisation application (MAA) or a marketing authorisation variation (MAV) of a medicinal product. It is also intended to help EDMF holders in the compilation of their EDMFs.