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EMA eSubmission Gateway now live

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Following a successful pilot, the European Medicines Agency (EMA) has announced that its eSubmission Gateway is now live for all applications for centralised marketing authorisations for human medicines. While CD and DVD formats continue to be accepted, the eSubmission Gateway means that it is possible for applicants to submit all types of eCTD human applications securely over the Internet to the EMA.  Certain national regulatory authorities in the EU have already established electronic portals for submissions and this development by the EMA is expected to promote the efficiency of centralised filings. 


At Wainwright Associates, using our state-of-the-art publishing systems, we publish and manage submissions across the full spectrum from paper, non-eCTD electronic submissions, to eCTD and ensure that your submission is compliant with the individual requirements of the receiving regulatory authorities.  To discuss your requirements please telephone +44 (0)1628 530554 or email

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