EMA Releases Final Active Substance Master File Guideline

EMA’s recently released final active substance master file (ASMF) guideline remains largely unchanged from the draft issued for comment in January.  The guideline is effective in October 2012.

The January draft, in turn, represented a rewrite of a 2006 draft, and was aimed at creating unique versions of ASMFs for each active substance that will be recognized by all EU regulatory agencies (IPQ “The News in Depth” February 28, 2012).

The main objective of the ASMF, previously known as the European drug master file, is to allow valuable confidential intellectual property or “know-how” of the manufacturer of the active substance to be protected, while at the same time allowing the applicant or marketing authorization holder (MAH) to take full responsibility for the medicinal product and the quality of the active substance. The new ASMF approach allows the national competent authorities and EMA to have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in a medicinal product.

In addition to several editorial changes, the final guideline was amended to direct marketing authorization holders to declare during the five-year renewal of the product that “the quality of the product, in respect of the methods of preparation and control, has been regularly updated by the variations procedure to take account of technical and scientific progress, and that the product confirms with current CHMP/CVMP quality guidelines.”

The template submission letter (Annex 3) in the final version calls for the inclusion of the Data Universal Numbering System (DUNS) and global positioning system (GPS) coordinates associated with the manufacturing site of the active substance manufacturer.


EMA Final Guideline on Active Substance Master File