According to the revised roadmap of the Electronic submissions for CEP applications published on November 2016, two main changes will be implemented as of 1 January 2018:
- eCTD will become mandatory for new CEP applications.
- 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.
If you need support to change the electronic format of your dossier do not hesitate to contact us at [email protected].
Asphalion has large experience in eCTD publishing, We can prepare the eCTD for you and submit directly by CESP.
