Drugdu.com expert's response:

The European Drug Master File (EDMF) and the United States Drug Master File (DMF) both comprehensively represent aspects of pharmaceutical production and quality, but due to their targeting of different markets, there are certain differences between them. Below is a detailed comparison of the two:

Ⅰ. Structure and Content

EDMF: Consists of four parts: EDMF Public Part, Confidential Part, Quality Overview Summary (QOS) Public Part, and QOS Confidential Part. The contents of these four parts overlap, but for the same content, the degree of description differs among the parts. For example, all four parts contain process descriptions, but only the Confidential Part includes the complete process, while the others only provide a brief overview of the process.

DMF: Comprises a single, comprehensive document without the clear sub-division seen in the EDMF. The content is relatively concentrated, covering detailed information on pharmaceutical production, quality, and other aspects.

Ⅱ. Quality Reference Standards

EDMF: Compiled with reference to the European Pharmacopoeia (EP). For raw materials, there are generally no specific requirements, but in special cases, officials may require testing according to the national pharmacopoeia, which is prominent in European submissions.

DMF: Compiled with reference to the United States Pharmacopeia (USP). It covers detailed information on human drug production facilities, processes, production, packaging, and storage, and can also include other types of information such as toxicology, risk assessment, and mitigation strategies.

III. Application and Review

EDMF: Pharmaceutical companies in EU member states submit the EDMF compiled by the raw material drug manufacturer along with their registration documents to the EU drug registration authorities for review. Upon approval, a reference number is issued, and this document can also be submitted to other pharmaceutical companies in EU member states for use. The application for EDMF must be made simultaneously with the marketing authorization application for the medicinal product using the raw material drug. It is reviewed by a single national authority as part of the marketing authorization application file for the medicinal product, along with the entire application file.

DMF: According to US laws and regulations, companies are not mandatory to submit a DMF, and the holder decides whether to submit it, which can also be submitted during the drug application process. It can be used for one or multiple applications, including New Drug Application (NDA), Investigational New Drug Application (IND), Abbreviated New Drug Application (i.e., generic drug application ANDA), export applications, and amendments and supplements to any of the above applications. The preparation and organization of DMF should strictly follow the format requirements of the Electronic Common Technical Document (eCTD). The submission of DMF aims to provide information for reference by parties other than the holder while ensuring that the content of the document is not disclosed.

Ⅳ. Other

EDMF: Applicable to all raw pharmaceutical materials, regardless of whether they have been included in the European Pharmacopoeia, which can enter the European market through the EDMF document. Once the EDMF document is submitted, the competent authorities of European countries or the European Medicines Agency (EMEA) will assess and question the public and confidential parts of the EDMF.

DMF: It is a widely referenced resource library for global pharmaceutical manufacturers. For raw material and excipient manufacturers seeking to enter the international market, DMF filing is very necessary. DMF holders must have a pre-assigned number and submit in the Electronic Common Technical Document (eCTD) format.

In summary, there are significant differences between EDMF and DMF in terms of structure, content, quality reference standards, application and review, and other aspects. These differences mainly stem from their targeting of different markets and the different regulatory requirements of each market.