IPEC e-newsletter - Excipients Insight November 2017 - 22-11-17


Inside this issue


Changes to CEP applications due in January

From 1 January, 2018, new Certificate of Suitability (CEO) applications to the European Directorate for the Quality of Medicines & Healthcare (EDQM) must be filed in electronic common technical document (eCTD) format.

On the same date, the EDQM will stop accepting PDF submissions for revisions and renewal applications. Therefore, all such submissions need to be either in NeeS (Non-eCTD electronic Submission) or eCTD format, says the regulator. There are a couple of exceptions - for TSE only submissions PDF will continue to be accepted, while for substances for veterinary use only, VNeeS (Veterinary Non-eCTD electronic Submission) will also be acceptable.

Last year, the EDQM noted that the number of electronic submissions has increased regularly, since it started encouraging their use in 2007, but noted that paper applications still represented about 10% of applications received.  The bulk were being received in PDF format, with eCTD accounting for around 20% of the total.




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