Half of all electronic submissions in France rejected for failing to meet NeeS format criteria
French health authority confirms it is currently returning 50% of NeeS regulatory submissions because of failure to conform to published standards, as Europe moves away from paper dossiers
DIA - Monaco - March 8th, 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, the French regulator, currently are in the NeeS format.
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 regulatory submissions and the electronic common technical document (eCTD) submission 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 organisations 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."
ISI is exhibiting on booth 179 at the 22nd Annual EuroMeeting in Monaco.
To find out more about ISI and its regulatory solutions, please link to http://www.imagesolutions.com/solutions.html
About Image Solutions, Inc.
Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations. For more information, visit the company website at www.imagesolutions.com.
Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.