Half of all NeeS dossiers rejected for poor formatting and inability to meet basic validation standards

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Mar 17 2010

The French health authority has revealed that it is rejecting half of all NeeS (non-eCTD electronic submissions) dossiers because they have been poorly formatted and do not meet basic validation standards. This is costing pharmaceutical companies time and money, as they re-work the submission format, and incur delays in getting their submissions reviewed and approved. Two-thirds of all electronic submissions to AFSSAPS currently are in the NeeS format.

“This is really quite shocking. France’s findings are sure to be echoed across other countries, suggesting that companies are having a harder time getting to grips with electronic standards than anticipated. This is a great shame, since this is so easy to get right with the right processes and tools.”

The startling discovery was made at last month’s Informa Life Sciences’ Lifecycle Management of the eCTD conference in Brussels, a twice-yearly forum to debate issues around the electronic common technical document (eCTD) standard, and NeeS, the halfway house.

The Brussels event featured presentations by health authorities from across Europe, whose representatives provided updates on each country’s NeeS and eCTD requirements. Germany, a large and important market, confirmed that it will now remove its requirement for paper dossiers from March, leaving Finland as the only major European country still to have a requirement for paper.

Commenting on the finding that so many electronic submissions are of a poor standard, Kate Wilber, Director of European Regulatory Services, at international submissions management specialist, Image Solutions Inc (ISI), said: “This is really quite shocking. France’s findings are sure to be echoed across other countries, suggesting that companies are having a harder time getting to grips with electronic standards than anticipated. This is a great shame, since this is so easy to get right with the right processes and tools.”

ISI is releasing a new, enhanced version of its flagship ISIPublisher software, which provides extensive support for NeeS submissions management, automating much of the crucial formatting so that organizations do not fall foul of health authority requirements. “In addition to its innovative technology, ISI has been equally committed to improving submission publishing cycle times so we are in line with increased workloads,” commented Kate. “One of our top pharma clients just did a performance metrics’ analysis and found that ISIPublisher version 3.2 was able to handle a volume of 621,000 pages in 1.28 minutes per 1,000 pages – a significant improvement from their internal baseline and previous versions of the product.”

Key features include:
- Creation of tables of contents with the appropriate entries to conform to NeeS guidance. This also offers increased flexibility in the creation of paper output.
- The ability to create and validate virtual bookmarks and hyperlinks—a feature that will assist publishing teams with generation of compliant navigable electronic output.
- Ability to replicate a publication and create a new publication, a significant time saving when managing NeeS formatted submissions at the national level.
- Document Management System browser update to support drag and drop of folder structures into the publication explorer structure.
- Pre-defined templates, which adhere to required naming standards.

“Most life sciences companies in Europe should now be working with the NeeS format at least. The majority are now, but it seems that many are doing it incorrectly,” Kate said, explaining that, while health authorities initially had no real standards to measure against, this situation changed in August 2009 when specific validation criteria were introduced. “Before, they accepted submissions blindly; now they are really pushing back and the consequences could be very costly for firms working to a schedule.”