eSubmission Gateway or web client to become mandatory for all eCTD submissions through the centralised procedure in 2014

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22/05/2013

eSubmission Gateway or web client to become mandatory for all eCTD submissions through the centralised procedure in 2014

From 1 March 2014, the use of the eSubmission Gateway or web client will become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralised procedure. After this date, the European Medicines Agency (EMA) will no longer accept these submissions on CD or DVD.

This applies to all marketing-authorisation and variation applications for human medicines.

The EMA's strategy for the electronic submission of applications aims to improve efficiency and decrease costs for applicants.

The EMA launched the electronic submission channel, eSubmission Gateway, in 2012 to allow secure submission over the internet for all types of eCTD applications for human medicines. The eSubmission web client was launched in January 2013 to complement the Gateway and is aimed for applicants with lower transmission volumes. The web-based tool may be more suitable for small and medium-sized companies.

The electronic submission channels offer the following benefits:

  • an easier and quicker way to send eCTD submissions securely over the internet, allowing sponsors to send updates within short timeframes;
  • feedback to the applicant on the receipt of the application, the outcome of eCTD technical validation and uploading to the EMA’s eCTD review system;
  • no need to submit physical copies of dossiers to the EMA.

Applicants are invited to register to use the eSubmission Gateway or the free web-client solution as soon as possible.

The EMA will extend the use of eSubmission Gateway and the web client to paediatric submissions, veterinary medicines and referral procedures in the near future.

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Contact point:

esubmission@ema.europa.eu