Are Some Regional Health Authorities Only Accepting PDF Version 1.4?

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Recently, some sponsors have been reporting the rejection of eCTD sequences or NeeS containing PDFs of any version other than 1.4.

The Swedish agency Medical Products Agency (MPA) states on their website on the page Electronic submissions to the MPA “The MPA will check eCTDs against the A criteria listed in the “EU eCTD Validation Criteria” v.2.0 (see link to the right), and also check for the B criteria that the eCTD has PDF files in format PDF 1.4 only (very important for archiving).” Some sponsors have reported that MPA is actually rejecting eSubmissions containing PDFs other than version 1.4, even though (as noted) this is only a “B” error in Europe (see Error 37 in EU eCTD Validation Criteria V2.1). The definition of “B” Priority is “accept but may request corrections (fix with a subsequent sequence)”.

The French authority Agence Française de Sécurité Sanitaire des Produits de Santé has also been reported to be refusing submissions containing PDFs other than 1.4, but I could not find anything on their web site to support this except a mention in NOTICE TO APPLICANTS FOR MARKETING AUTHORISATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE  as follows: “The file format for text documents must be PDF 1.4”.

ICH’s guidance on this (in the eCTD 3.2.2 specs) is “All ICH Regional Health Authorities are able to read and have agreed to accept PDF files saved as PDF version 1.4… Please consult regional guidance to submit other versions of PDF.” FDA of course has a whole document on this topic, Portable Document Format Specifications (note the new location on their re-organized web site). I have heard FDA say in the past that their issue with PDF formats is also archiving, as their reviewers have long since moved past Adobe versions that can only handle version 1.4.

If you are submitting to regional authorities in Europe, you may wish to check with those authorities and also to run your submission through the Belgian Registration file validation.  Also keep in mind that one of your biggest issues could be literature references, which may be supplied to you in PDF format. If it’s not possible to “save down” to V1.4, worst case you might have to scan to V1.4.

Author: GS

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