Stephen LoCastro

Director, Regulatory Affairs

May 18, 2017

FDA and Health Canada Requirements for Electronic Drug Master Files

Both the FDA and Health Canada have issued guidances to industry that require Drug Master Files (DMFs) to be provided in electronic formats by defined deadlines.

Health Canada has required that DMFs be filed in an electronic (non-eCTD) format, at minimum, since April 2016.

FDA (CBER and CDER) will require all new DMFs and amendments to existing ones on file with those agencies to be in eCTD format beginning May 5, 2018.1

Good news! If your company relies on West DMFs to support their drug applications, you don’t have to worry. Since April 2016, all West DMFs held with CBER, CDER, and Health Canada are in eCTD format and conform to the agencies’ requirements.

West approached both agencies in 2014 with a proposal to establish eCTD requirements for packaging DMFs. Over the course of a year, we collaborated with each agency’s DMF content and electronic submissions experts to create a single set of requirements that were acceptable to industry and the agencies.

In addition, West drove agreements on procedures for managing the transition to eCTD in a way that limited impact to our customers, while minimizing the administrative burden for each regulatory agency.

As a result of our proactive approach, West filed the first eCTD packaging DMFs with both the FDA and Health Canada in late 2015.

Please note that we have worked out a plan with the three agencies to permit existing West LOA holders to continue using their current Letters of Authorization/Access (LOAs). If you are using an LOA that references the previous paper version of a West DMF, you do not need a new one.

Please also note that FDA requirements for eCTD DMFs do not apply to CDRH, which has opted not to accept them in this format at this time. West DMFs filed with this agency remain as paper documents.

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