Regulatory information - eSubmission Gateway or web client mandatory for all eCTD submissions through the centralised procedure from 1 March 2014

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07/02/2014

Regulatory information - eSubmission Gateway or web client mandatory for all eCTD submissions through the centralised procedure from 1 March 2014

The European Medicines Agency (EMA) reminds marketing authorisation holders that 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 Agency will no longer accept submissions saved onto CD or DVD. This will apply to all types of procedures, including active substance master file (ASMF) submissions.

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

  • quicker and easier way to send electronic submissions securely over the internet, allowing sponsors to send updates in very short timeframes;
  • feedback to the applicant on receipt of the application and, in the case of Centralised Procedure eCTD submissions, confirmation of the outcome of the eCTD technical validation and subsequent upload to the EMA’s eCTD review system;
  • no need to submit physical copies of dossiers or hard copy cover letters to the EMA.

Applicants who have not already done so are invited to register to use the eSubmission Gateway or the free web-based web client solution as soon as possible.

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