Drug Master Files: Requirements and Challenges - Pharmaceutical Technology

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Drug Master Files: Requirements and Challenges
The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates.

Pharmaceutical Technology
Volume 33, Issue 9

However different countries have different requirements within the EU. The United Kingdom and The Netherlands will only accept electronic copies each in their own separate electronic format, while France requires both a paper copy and an electronic copy. France also requires special application forms to accompany the DMF as well as a letter certifying that the electronic version is identical to the paper copy. Several other countries are in the process of converting to the non-ICH (XML), non-eCTD electronic submissions (NeeS) electronic filing format (4). These include Belgium, Denmark, Germany, France, Hungary, Portugal, Spain, and Sweden. In addition, Canada and Australia have different DMF Type designations than the United States. Future international submissions will probably adapt the ICH-recommended XML format (5)

Table I highlights many for the world's health authorities'particular requirements for the submission of DMFs and ASMFs.

With the international movement to submit electronic documentation of marketing applications for the approval and sale of pharmaceuticals, DMFs submitted in many countries have yet to follow this trend. Although several EU countries have initiated the conversion to electronic copies of ASMFs, the majority of the world's health agencies are still requiring several bulky paper copies. In addition, many countries still do not assign a registration number to a submitted DMF or ASMF, which may cause confusion. This could become an issue in light of the pharmaceutical industry's trend to consolidate.

Although the CTD format has brought significant consistency to the preparation of DMFs and ASMFs, many different filing conventions still remain. The universal acceptance of a single electronic format and associated paperwork is still in the future.

Thomas Warden is president of Warden Consulting, 4312 Whippeny Dr., Fort Collins, CO 80526, tel. 970.225.9789,


1. ICH, Organization of the Common Technical Document For Registration Of Pharmaceuticals For Human Use M4, Rev.4 (Brussels, Belgium, Nov. 2005) http://www.ich.org/.

2. FDA, Guideline for Drug Master Files (Rockville, MD, Sept. 1989) http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm, accessed Aug. 24, 2009.

3. Personal communication, Sharon Brownewell, FDA, CDER, May 2009.

4. EMEA, EU Telematic Implementation Group – Electronic Submissions (TGes), Guidance for Industry on Providing Regulatory Information in Electronic format: Non-eCTD Electronic submissions, Ver. 1.4 (Strasbourg, France, Jan. 2008) http://www.cbg-meb.nl/.

5. ICH, ICH M2 ENG, ICH Common Technical Document Specification, V. 3.2 (Brussels, Belgium, Feb. 4, 2004) http://www.ich.org/.


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