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ASMF/DMF

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An Active Substance Master File (ASMF) or Drug Master File (DMF) is a document submitted to the regulatory authorities, containing data about the chemistry, manufacturing and controls of a drug substance. The scientific part of an ASMF (or DMF in case of submission to e.g. USA and Switzerland) is divided into two parts, namely the Applicant's Part (AP) and Restricted Part (RP). This dossier is provided as a standalone dossier but submitted in conjunction with the main application for a new medicinal product.

Since several years it is mandatory to either use the structured NeeS or the eCTD format for submission of an ASMF to EMA. However, EMA strongly encourages the presentation of ASMFs linked to human medicinal products in eCTD format. Therefore, authorisation holders of already approved ASMFs in non-eCTD format should also consider converting their ASMF into an eCTD at the latest when the next update is due to be filed or preferably at an earlier stage independent from any regulatory activity (baseline submission). Although an ASMF/DMF complies with the standardised CTD structure, there are country-specific requirements that have to be taken into account, e.g. Switzerland uses quite complex procedures regarding the forms to be submitted, specific requirements regarding hyperlinks provided in the documentation etc.


ERA can support you with the electronic compilation of your ASMF/DMF according to relevant guidelines(NeeS/eCTD) or the conversion of your existing paper-/NeeS-based ASMF/DMF into eCTD format. We can also manage the submission of your electronic application to the regulatory authorities.


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