miércoles, 25 de abril de 2018

Compliance date extended to May 5, 2019 for submitting Type III Drug Master Files (DMFs) in electronic Common Technical Document (eCTD) format

Guidance for Industry

The Food and Drug Administration (FDA) is announcing that it is extending the compliance date for submitting Type III drug master files (DMFs) in electronic common technical document (eCTD) format by one year to May 5, 2019. Type III DMFs are related to packaging materials. Only the implementation date for type III DMFs is changing.

The requirement to submit DMFs using eCTD format is part of FDA’s overall effort to more efficiently review drug applications. eCTD standardizes how industry submits applications, amendments, supplements, and reports. In response to industry comments and internal review, FDA determined that it is appropriate to extend the required date to submit Type III DMFs by one year. FDA continues to recommend the use of eCTD format for Type III DMFs, however the extension will help avoid potential supply disruptions that may have occurred if Type III master files were rejected. In addition, only a small portion of Type III DMFs submitted to FDA require assessment by FDA staff in support of a marketing applications; in most cases, the information needed to support approval is already present in the marketing application.

The FDA has a number of resources to help DMF holders understand eCTD format and how to submit using eCTD:

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