New opportunities for Pharma companies!

Now Pharma companies can use audio and video files to support their promotional material during marketing authorisation applications, making the entire process more engaging.

Over the last few months, the FDA has updated the file formats that are permitted within the eCTD. New formats have been added to the file format specification “Specifications for File Format Types Using eCTD Specifications”, now in its version 7.0.

  • In March 2021, the following file types for modelling and simulation were added: .cmpx, cmpz, .wksx, .wksz, ,lbrx, .lbrz, .mdb, .pbk, .opd, .psd, .spd .c, .cpp, .m, .mat, .rmd, .phxproj, .py, .jl, .cas, .dat.
  • In May 2021, the chemical file type .sdf was added.
  • And in October 2021 the file type .zip was added to allow grouping of large sets of aECG xml files.

The “Specifications for File Format Types Using eCTD Specifications” specifies that in general, documents should be provided in searchable PDF format. Other document types as well as images should be rendered into PDF, maintaining searchability were possible. However, other types of file formats are acceptable in the eCTD and many new file types have been added this year.

Besides the more common document file types such as .doc and .docx or image formats such as .gif, .bmp, the FDA now also permits audio and video file formats in Module 1.15 Promotional Material.

New this year are file formats for modelling and simulation with the additional file types as outlined above. These file types are permitted by the FDA in Module 5 Clinical Study Reports (CDER only). No additional archiving format has been provided.

In May this year, the structured data file format or .sdf was added, which will be accepted in Module 3.2.P.5.5 (Characterization of Impurities) as well as Module 3.2.S.3.2 (Impurities).

One further addition has just been added in October 2021, which is the .zip file format for grouping of large sets of aECG (annotated Electrocardiogram) xml files.

In summary

With the addition of new file types such as audio and video, further opportunities are opening up for marketing authorisation holders to complement their promotional material and make use of new technologies.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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