The European Medicines Agency (EMA) and the 32 national competent authorities in Europe are almost at the finishing line of the race to complete the switch to eCTD submissions. If you used to send your application via CD/DVD and got in to the trap of having it lost by the post office, or not receiving confirmation from the agency about receiving your submission; this will no longer be an issue as the agencies have platforms to accept the submissions.
In this article, we will talk about EMA eSubmission gateway, CESP (Common European Submission Platform) and the future of both platforms; CESSP (Common European Single Submission Portal).
EMA eSubmission gateway or Webclient for centralised procedures
For MAAs (Marketing Authorisation Applications) planned via the centralised procedure in the EU, you need to send your submission via EMA eSubmission gateway or Webclient, represented in Figure 1. Since March 2014 for human medicines and January 2017 for Veterinary medicines, the EMA no longer accepts CDs/ DVDs or submissions via Eudralink.
The use of xml delivery files are mandatory, for which the relevant delivery files are available. In cases where delivery files are not available – as for example for ancillary medicinal substances in medical device, use of file naming conventions is allowed. In the references below, you can find the links for creating your XML delivery files as well the file naming convention in those exceptional cases.