Are Some Regional Health Authorities Only Accepting PDF Version 1.4?

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...

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EMEA Posts Documents to Support M1 Update

If you visit the EMEA eSubmission: What’s new page, you will see that several new documents have been posted (date says July 27th, but I think it was really after that…) The updated documents are: Updated EU Telematics EU eCTD Change Request/Q&A Tracking Table EU Validation Criteria v2.0 EA Practical/Technical Q&A on eCTD Submission V0.4 These updates are mainly in support of the recent EU Updated M1 v1.3 (see my...

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Submitting Documents with Track Changes

Recently, I have come across several instances where applicants or regulators have discussed submitting documents with tracked changes. Clearly, there is some guidance for this in the area of EU and US labeling, but this was the first that I had heard of it potentially being done elsewhere in a dossier. The first was at DIA, where Norman Schuff of the FDA recommended submitting Module 3 replacement documents with tracked changes...

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